Drugs for Human Use; Drug Efficacy Study Implementation; Certain Prescription Drugs Offered for Various Indications; Opportunity To Affirm Outstanding Hearing Request, 43337-43342 [2012-18015]
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Federal Register / Vol. 77, No. 142 / Tuesday, July 24, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
Citation
Number of
disclosures
per
respondent
Total annual
disclosures
Average burden
per disclosure
Total hours
21 CFR 101.105 ................................................................
Section 403(w)(1) of the FD&C Act ...................................
Guidance document entitled ‘‘Labeling of Certain Beers
Subject to the Labeling Jurisdiction of the Food and
Drug Administration’’ ......................................................
12
12
2
2
24
24
0.5
1
12
24
12
1
12
1
12
Total ............................................................................
........................
........................
........................
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1 There
..........................
186
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimate of the number of
respondents in table 1 is based on the
number of regulatory submissions
submitted to TTB for beers that do not
meet the definition of a ‘‘malt beverage’’
under the FAA Act. Based on its records
of submissions received from
manufacturers of such products, TTB
estimates the number of respondents to
be 12 and the number of disclosures
annually to be 24. Thus, FDA adopts
TTB’s estimate of 12 respondents, and
an annual number of disclosures per
respondent of 2, in table 1 of this
document.
FDA’s estimate of the average burden
per disclosure for each regulation are
based on FDA’s experience with food
labeling under the Agency’s
jurisdiction. The estimated average
burden per disclosure for §§ 101.3,
101.4, 101.5, 101.9, 101.22, and 101.105
in table 1 are equal to, and based upon,
the estimated average burden per
disclosure approved by OMB in OMB
control number 0910–0381. FDA further
estimates that the labeling burden of
section 403(w)(1) of the FD&C Act,
which specifies requirements for the
declaration of food allergens, will be 1
hour based upon the similarity of the
requirements to that of § 101.4. Finally,
FDA estimates that a respondent will
spend 1 hour reading the guidance
document.
Thus, FDA estimates that 12
respondents will each label 2 products
annually, for a total of 24 labels. FDA
estimates that the manufacturers will
spend 7.25 hours (0.5 hours + 1 hour +
0.25 hour + 4 hours + 0.5 hour + 1 hour
= 7.25 hours) on each label to comply
with FDA’s labeling regulations and the
requirements of section 403(w)(1) of the
FD&C Act, for a total of 174 hours (24
labels × 7.25 hours = 174 hours). In
addition, 12 respondents will each
spend 1 hour reading the guidance
document, for a total of 12 hours. Thus,
FDA estimates the total hour burden of
the proposed collection of information
to be 186 hours (174 hours + 12 hours
= 186 hours).
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The draft guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in
§§ 101.3, 101.4, 101.5, 101.9, 101.22,
and 101.105 have been approved under
OMB control number 0910–0381.
II. References
The following references have been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site addresses, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. Memorandum of Understanding
225–88–2000 between FDA and Bureau
of Alcohol, Tobacco and Firearms,
available at https://www.fda.gov/
AboutFDA/PartnershipsCollaborations/
MemorandaofUnderstandingMOUs/
DomesticMOUs/ucm116370.htm.
2. TTB Ruling 2008–3 dated July 7,
2008, available at https://www.ttb.gov/
rulings/2008-3.pdf.
Dated: July 16, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–18028 Filed 7–23–12; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–1975–N–0336 (Formerly
75N–0184), FDA–1975–N–0355 (Formerly
75N–0185), FDA–1976–N–0272 (Formerly
76N–0056), FDA–1976–N–0344 (Formerly
76N–0057), FDA–1978–N–0701 (Formerly
78N–0070), FDA–1979–N–0224 (Formerly
79N–0169), FDA–1983–N–0297 (Formerly
83N–0030), and FDA–1988–N–0004
(Formerly 88N–0242); DESI 597, 1626, 3265,
10837, 12283, and 50213, and
Hydrocortisone Acetate and Pramoxine
Hydrochloride]
Drugs for Human Use; Drug Efficacy
Study Implementation; Certain
Prescription Drugs Offered for Various
Indications; Opportunity To Affirm
Outstanding Hearing Request
ACTION:
Notice.
The Food and Drug
Administration (FDA) is offering an
opportunity to affirm outstanding
hearing requests pertaining to several
dockets. FDA will assume that
companies with outstanding hearing
requests that do not respond to this
notice are no longer interested in
pursuing their requests, and will deem
the requests withdrawn.
DATES: Effective Date: This notice is
effective August 23, 2012.
Hearing Requests: Hearing requests
must be affirmed by notifying FDA by
August 23, 2012. Hearing requests not
affirmed within that timeframe will be
deemed withdrawn.
ADDRESSES: Requests to affirm or
withdraw outstanding hearing requests,
as well as all other communications in
response to this notice, should be
identified with the appropriate docket
number, and directed to Pamela Lee,
Office of Unapproved Drugs and
Labeling Compliance, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 5173,
Silver Spring, MD 20993–0002.
SUMMARY:
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Federal Register / Vol. 77, No. 142 / Tuesday, July 24, 2012 / Notices
FOR FURTHER INFORMATION CONTACT:
Pamela Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 5173, Silver Spring,
MD 20993–0002, 301–796–3297, email:
pamela.lee@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The Food
and Drug Administration (FDA) is
offering an opportunity to affirm
outstanding hearing requests pertaining
to FDA Docket Nos. FDA–1975–N–0336
(formerly 75N–0184) (DESI 597); FDA–
1976–N–0272 (formerly 76N–0056),
FDA–1976–N–0344 (formerly 76N–
0057), and FDA–1978–N–0701 (formerly
78N–0070) (DESI 1626); FDA–1975–N–
0355 (formerly 75N–0185) (DESI 3265);
FDA–1975–N–0336 (formerly 75N–
0184) (DESI 10837); FDA–1979–N–0224
(formerly 79N–0169) (DESI 12283);
FDA–1983–N–0297 (formerly 83N–
0030) (DESI 50213); and FDA–1988–N–
0004 (formerly 88N–0242).
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I. Background
When initially enacted in 1938, the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) required that ‘‘new
drugs’’ (see 21 U.S.C. 321(p)) be
approved for safety by FDA before they
could legally be sold in interstate
commerce. To this end, the FD&C Act
made it the sponsor’s responsibility,
before marketing a new drug, to submit
a new drug application (NDA) to FDA
to prove that its drug was safe. Between
1938 and 1962, if a drug obtained
approval, FDA considered drugs that
were identical, related, or similar (IRS)
(see (21 CFR 310.6(b)(1)) to the
approved drug to be ‘‘covered’’ by that
approval, and allowed those IRS drugs
to be marketed without independent
approval.
In 1962, Congress amended the FD&C
Act to require that new drugs be proven
effective for their labeled indications, as
well as safe, to obtain FDA approval.
This amendment also necessitated that
FDA conduct a retrospective evaluation
of the effectiveness of the drug products
that FDA had approved as safe between
1938 and 1962. FDA contracted with the
National Academy of Sciences/National
Research Council (NAS/NRC) to make
an initial evaluation of the effectiveness
of over 3,400 products that had been
approved only for safety between 1938
and 1962. The NAS/NRC reports for
these drug products were submitted to
FDA in the late 1960s and early 1970s.
The Agency reviewed and reevaluated
the reports and published its findings in
Federal Register notices. FDA’s
administrative implementation of the
NAS/NRC reports was called the Drug
Efficacy Study Implementation (DESI).
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DESI covered the approximately 3,400
products specifically reviewed by the
NAS/NRC, as well as the even larger
number of IRS products that entered the
market without FDA approval.
All drugs covered by the DESI review
are ‘‘new drugs’’ under the FD&C Act.
If FDA’s final DESI determination
classifies a drug product as lacking
substantial evidence of effectiveness for
one or more indications, that drug
product and those IRS to it may no
longer be marketed for the indications
and are subject to enforcement action as
unapproved new drugs. If FDA’s final
DESI determination classifies the drug
product as effective for one or more of
its labeled indications, the drug can be
marketed for those indications,
provided it is the subject of an
application approved for safety and
effectiveness. Sponsors of drug products
that have been found to be effective for
one or more indications through the
DESI process may rely on FDA’s
effectiveness determinations, but
typically must update their labeling to
conform to the indications found to be
effective by FDA and to include any
additional safety information required
by FDA. Those drug products with
NDAs approved before 1962 for safety
therefore require approved supplements
to their original applications if found to
be effective under DESI; IRS drug
products require an approved NDA or
abbreviated new drug application
(ANDA), as appropriate. Furthermore,
labeling for drug products classified as
effective may contain only those
indications for which the review found
the product effective unless the firm
marketing the product has received an
approval for the additional
indication(s).
II. Outstanding Hearing Requests
Pertaining to Docket Nos. FDA–1975–
N–0336 (Formerly 75N–0184) (DESI
597); FDA–1976–N–0272 (Formerly
76N–0056), FDA–1976–N–0344
(Formerly 76N–0057), and FDA–1978–
N–0701 (Formerly 78N–0070) (DESI
1626); FDA–1975–N–0355 (Formerly
75N–0185) (DESI 3265); FDA–1975–N–
0336 (Formerly 75N–0184) (DESI
10837); FDA–1979–N–0224 (Formerly
79N–0169) (DESI 12283); FDA–1983–N–
0297 (Formerly 83N–0030) (DESI
50213); and FDA–1988–N–0004
(Formerly 88N–0242)
In 2006, FDA announced a new drug
safety initiative to address unapproved
drugs currently being marketed in the
United States, and to facilitate a rational
process to bring all such unapproved
drugs into the approval process. As part
of the Unapproved Drugs Initiative, the
Office of Compliance of the Center for
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Drug Evaluation and Research is
reviewing proceedings that remain open
under DESI. According to FDA’s
records, the dockets discussed in this
document contain pending hearing
requests.
This Federal Register notice identifies
the products that are the subjects of
hearing requests to the extent possible
based on the information contained in
the hearing requests. In some cases, the
companies requesting hearings
identified the product that was the
subject of the hearing request by name.
In other cases, the company simply
identified the subject of its hearing
request as a product that is IRS to one
of the products reviewed under DESI. In
yet other cases, there is no information
provided by the requester about the
product that is the subject of its hearing
request.
In cases where FDA was able to obtain
current contact information for a
company (or its successor-in-interest) or
its representative, FDA sent letters
directly to the companies (or their
successors-in-interest) and/or their
representatives requesting that
outstanding hearing requests be
withdrawn or affirmed within a
specified timeframe. In some cases,
however, FDA was unable to find
current contact information for the
companies that requested hearings.
Because many of the products that are
the subjects of these hearing requests
may no longer be marketed and some of
the companies that requested hearings
may no longer be in business, FDA is
seeking to determine whether there is
continued interest in pursuing these
outstanding hearing requests. It should
be noted that the discussion of DESI
dockets does not provide a
comprehensive historical record of each
docket and, therefore, will not identify
every request that had been previously
addressed.
Through this Federal Register notice,
FDA seeks to have any company with an
outstanding hearing request covered by
this notice that has not already
responded to a direct communication
from FDA either withdraw or affirm its
hearing request. FDA will assume that
companies with outstanding hearing
requests that do not respond to this
notice are no longer in business and/or
do not have a continuing interest in the
hearings, and FDA will deem their
requests withdrawn.
To withdraw an outstanding hearing
request, a company (or its successor-ininterest) or its representative should
send a letter stating its intention to do
so to Pamela Lee (see ADDRESSES). The
letter should include the docket number
of the proceeding, as well as the name
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and National Drug Code (NDC) number
of the product that is the subject of the
hearing request.
To affirm an outstanding hearing
request, a company (or its successor-ininterest) or its representative should
send a letter stating its intention to do
so to Pamela Lee (see ADDRESSES). The
letter should include the docket number
of the proceeding, as well as the name
and NDC number of the product that is
the subject of the hearing request.
Letters affirming outstanding hearing
requests must be postmarked or emailed
by the date specified in this notice (see
DATES). Only currently outstanding
hearing requests may be affirmed; this
notice does not provide a new
opportunity to request a hearing under
any of these dockets.
A. Certain Drug Products Containing an
Anticholinergic in Combination With a
Barbituate; Docket No. FDA–1975–N–
0336 (Formerly 75N–0184) (DESI 597)
Under Docket No. FDA–1975–N–0336
(formerly 75N–0184), FDA determined
that certain drug products containing an
anticholinergic in combination with a
barbiturate lacked substantial evidence
of effectiveness for various
gastrointestinal disorders, and offered
an opportunity for hearing regarding its
conclusion (48 FR 20495, May 6, 1983).
In response to the May 1983 notice, the
following companies filed timely
hearing requests: A.H. Robins Co. (now
part of Pfizer, Inc., 235 East 42nd St.,
New York, NY 10017), regarding
Donnatal Tablets (ANDA 86–676),
Capsules (ANDA 86–677), and Elixir
(ANDA 86–661); B.F. Ascher & Co., Inc.,
15501 W. 109th St., Lenexa, KS 66219,
regarding Anaspaz-PB; Bay Laboratories,
Inc., 3654 West Jarvis, Skokie, IL 60076,
regarding Bay-Ase Elixir (ANDA 86–
673); Beecham Laboratories, a Division
of Beecham, Inc. (now part of Glaxo
SmithKline, 200 N 16th St., #1,
Philadelphia, PA 19102), regarding
Hybephen (ANDA 86–573); CarterWallace, Inc. (now part of Meda
Pharmaceuticals, Inc., 265 Davidson
Ave., Suite 300, Somerset, NJ 08873–
4120), regarding Barbidonna Tablets
(ANDA 86–589), Barbidonna Elixir
(ANDA 86–590), and Barbidonna No. 2
Tablets (ANDA 87–572); Ferndale
Laboratories, Inc. (now part of Ferndale
Pharma Group, Inc., 780 W. Eight Mile
Rd., Ferndale, MI 48220), regarding
Bellkatal Tablets and Pheno-Bella
Tablets; Halsey Drug Co., Inc. (now part
of Acura Pharmaceuticals, Inc., 616 N.
North Court, Suite 120, Palatine, IL
60067), regarding Susano Elixir (ANDA
86–587) and Susano Tablets (ANDA 86–
588); Kremers-Urban Co. (now part of
Kremers-Urban Pharmaceuticals, Inc.,
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902 Carnegie Center, Suite 360,
Princeton, NJ 08540), regarding Levsin
with Phenobarbital Tablets (ANDA 86–
640); Lemmon Co. (now part of Teva
Pharmaceuticals, 1090 Horsham Rd.,
P.O. Box 1090, North Wales, PA 19454–
1090), regarding Belladonna Alkaloids
and Phenobarbital Tablets (ANDA 86–
591); McNeil Pharmaceutical (now part
of Ortho-McNeil-Janssen
Pharmaceuticals, Inc., 1125 TrentonHarbourton Rd., P.O. Box 200,
Titusville, NJ 08568), regarding Butibel
Tablets and Butibel Elixir (ANDA 86–
664); National Pharmaceutical
Manufacturing Co. (now part of Actavis
US, 60 Columbia Rd., Bldg. B,
Morristown, NJ 07960), regarding
Barophen Elixir (ANDA 86–546) and
Butabar Belladonna Elixir (ANDA 86–
561); Purepac Pharmaceutical (now part
of Actavis US, 60 Columbia Rd., Bldg.
B, Morristown, NJ 07960), regarding
Belladonna Alkaloids with
Phenobarbital Tablets and Elixir; ReidProvident Laboratories, Inc. (now part of
Abbott Laboratories, 100 Abbott Park
Rd., Abbott Park, IL 60064–3500),
regarding Spalix Elixir (ANDA 86–652)
and Spalix Tablets (ANDA 86–653);
Richlyn Laboratories, Inc. (now part of
Impax Laboratories, Inc., 30831
Huntwood Ave., Hayward, CA 94544),
regarding Bellophen (ANDA 86–687)
and Spasmolin (ANDA 86–655);
Sandoz, Inc., 506 Carnegie Center, Suite
400, Princeton, NJ 08540, regarding
Belladenal Tablets (ANDA 86–668) and
Belladenal S Tablets (ANDA 87–198);
Stuart Pharmaceuticals, Division of ICI
Americas, Inc. (now part of AstraZeneca
Pharmaceuticals LP, 1800 Concord Pike,
P.O. Box 15437, Wilmington, DE 19850–
5437), regarding Kinesed Tablets; Vale
Chemical Co., Inc., 1201 Liberty St.,
Allentown, PA 18102, regarding
Barbeloid Tablets, Green (NDA 85–532)
and Barbeloid Tablets, Yellow (NDA
86–549); West-ward Pharmaceutical
Corp., 401 Industrial Way West,
Eatontown, NJ 07724–2206, regarding
Belladonna Alkaloid with Phenobarbital
Tablets; William P. Poythress & Co.,
Inc., 16 N. 22nd St., P.O. Box 26946,
Richmond, VA 23261, regarding
unidentified products composed of
atropine sulfate 0.195 milligrams (mg)
in combination with phenobarbital 16
mg; William Rorer, Inc. (now part of
Sanofi-Aventis U.S., 55 Corporate Dr.,
Bridgewater, NJ 08807), regarding
Chardonna-2 Tablets (ANDA 86–585);
and Wharton Laboratories, Inc., 48th
Ave., Long Island City, NY 11101,
regarding Bellastal Capsules (ANDA 86–
657).
In May, June, and July 2011, FDA sent
letters to the following companies
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43339
requesting that they withdraw or affirm
their outstanding hearing requests under
this docket within 30 days: Pfizer, Inc.;
B.F. Ascher & Co., Inc.; Glaxo
SmithKline; Meda Pharmaceuticals,
Inc.; Ferndale Pharma Group, Inc.;
Acura Pharmaceutical Co.; KremersUrban Pharmaceuticals, Inc.; Teva
Pharmaceuticals; Ortho-McNeil-Janssen
Pharmaceuticals, Inc.; Actavis US;
Abbott Laboratories; Impax
Laboratories, Inc.; Sandoz, Inc.;
AstraZeneca Pharmaceuticals LP; Westward Pharmaceutical Corp.; and SanofiAventis U.S.
On May 24, 2011, Actavis US
withdrew the hearing request filed by
National Pharmaceutical Manufacturing
Co. On May 26, 2011, Teva
Pharmaceuticals and Impax
Laboratories, Inc., withdrew the hearing
requests filed by Lemmon Co. and
Richlyn Laboratories, Inc., respectively.
On June 2, 2011, Ferndale Pharma
Group, Inc., withdrew its hearing
request. On June 3, 2011, AstraZeneca
Pharmaceuticals, LP, withdrew the
hearing request filed by Stuart
Pharmaceuticals. On June 6, 2011,
Acura Pharmaceutical Co. withdrew the
hearing request filed by Halsey Drug
Co., Inc. On June 7, 2011, Johnson &
Johnson Pharmaceutical Research &
Development, LLC, responded to the
letter sent to Ortho-McNeil-Janssen
Pharmaceuticals, Inc., stating that the
rights to Butibel Elixir had been
transferred to Carter Wallace in 1982.
On June 20, 2011, B.F. Ascher & Co.,
Inc., withdrew its hearing request. On
June 22, 2011, Novartis Pharmaceuticals
Corp., the successor-in-interest by
merger to Sandoz, Inc., withdrew
Sandoz, Inc.’s hearing request. On July
7, 2011, Meda Pharmaceuticals, Inc.,
withdrew the hearing request filed by
Carter-Wallace, Inc., as well as the
hearing request filed by McNeil
Pharmaceutical for Butibel Tablets and
Elixir. On July 27, 2011, Kremers-Urban
Co. withdrew its hearing request. On
August 11, 2011, GlaxoSmithKline
withdrew the hearing request filed by
Beecham Laboratories. On August 24,
2011, Abbott Laboratories withdrew the
hearing request filed by Reid-Provident
Laboratories, Inc.
On July 6, 2011, West-ward
Pharmaceutical Corp. affirmed its
hearing request and PBM
Pharmaceuticals, Inc., affirmed the
hearing request filed by A.H. Robins
Co., as the asserted successor-in-interest
to A.H. Robins Co.’s hearing request. A
Federal Register notice issued on June
8, 2011 (76 FR 33310), withdrew the
approval of 70 NDAs and 97 ANDAs.
This included the withdrawal of the
approval for Donnatal Capsules and
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withdrawal of the conditional approval
for the Donnatal Tablets and Elixir. This
withdrawal notice was subsequently
corrected to note that the approval and
conditional approvals for these products
were still in effect, because PBM
Pharmaceuticals, Inc., had acquired the
rights to the ANDAs and had informed
FDA before the withdrawal would have
become effective that it did not want the
ANDAs withdrawn (76 FR 79701,
December 22, 2011).
As of April 1, 2012, Actavis U.S. (with
respect to the hearing request filed by
Purepac Pharmaceutical) and SanofiAventis U.S. had not responded to FDA.
FDA was unable to find current contact
information for Bay Laboratories, Inc.;
Vale Chemical Co., Inc.; William P.
Poythress & Co., Inc.; and Wharton
Laboratories, Inc. If any of these
companies, or any successor-in-interest,
continues to have an interest in
pursuing its hearing request under this
docket, the companies (or their
successors-in-interest) must affirm their
hearing requests in writing by the date
specified in this notice (see DATES). FDA
will assume that hearing requests that
are not affirmed within that timeframe
are no longer being pursued, and will
deem them withdrawn.
B. Combination Drugs Containing a
Xanthine Derivative; Docket No. FDA–
1976–N–0272 (Formerly 76N–0056),
FDA–1976–N–0344 (Formerly 76N–
0057), and FDA–1978–N–0701
(Formerly 78N–0070) (DESI 1626)
In 1972, FDA classified certain
combination drug products containing a
xanthine derivative as less than effective
for some labeled indications and
possibly effective for other labeled
indications (37 FR 14895, July 26, 1972).
As described in a Federal Register
notice of February 29, 1984, FDA
subsequently handled these products in
three groups: (1) Combinations
containing more than 2 grains of
xanthine derivative, more than 8 mg of
phenobarbital, and/or an ingredient not
considered as part of the over-thecounter (OTC) drug review (Docket No.
FDA–1976–N–0272 (formerly 76N–
0056)); (2) combinations containing 2
grains or less of a xanthine derivative,
ephedrine, and 8 mg or less of
phenobarbital (Docket No. FDA–1976–
N–0344 (formerly 76N–0057)); and (3)
combinations containing theophylline,
ephedrine, and hydroxyzine
hydrochloride (HCl) (Docket No. FDA–
1978–N–0701 (formerly 78N–0070)) (49
FR 7454, February 29, 1984).
In 1976, FDA reclassified certain
combination preparations containing a
xanthine derivative to lacking
substantial evidence of effectiveness,
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proposed withdrawing associated
NDAs, and offered an opportunity for
hearing regarding its proposal (41 FR
15051, April 9, 1976). The group of
products addressed in the April 1976
notice contained more than 2 grains of
xanthine derivative, a barbiturate in
higher strength than the equivalent of
8 mg of phenobarbital, and/or an
ingredient not considered as part of the
OTC drug review (Docket No. FDA–
1976–N–0272 (formerly 76N–0056))
(id.). The holders of the NDAs listed in
the April 1976 notice did not request
hearings, and those NDAs were
withdrawn in October 1977 (42 FR
54620, October 7, 1977). However, in
response to the April 1976 notice, the
following companies filed timely
hearing requests: Knoll Pharmaceutical
Co. (now part of Abbott Laboratories,
100 Abbott Park Rd., Abbott Park, IL
60064–3500), regarding Quadrinal
Tablets and Suspension, and Mead
Johnson Laboratories (now Mead
Johnson Nutrition, 4th Floor, 2701
Patriot Blvd., Glenview, IL 60026),
regarding Quibron Plus Capsules and
Elixir.
In 1984, FDA amended the April 1976
notice to include its analysis of new
information regarding combination
products containing a xanthine
derivative (49 FR 7454, February 29,
1984). Based on its analysis of the new
information, FDA concluded that there
is a lack of substantial evidence that:
(1) Each ingredient contributes to the
claimed effect of such combination drug
products, and (2) the dosage of each
component is such that the
combinations are safe and effective for
a significant patient population (id.).
Therefore, FDA proposed in the 1984
notice to withdraw approval of the
applications for combination products
containing a xandine derivative, and
offered an opportunity for hearing
regarding its proposal. In response to
the February 1984 notice, the following
companies filed timely hearing requests:
National Pharmaceutical Manufacturing
Co. (now part of Actavis US, 60
Columbia Rd., Bldg. B, Morristown, NJ
07960), regarding Brondelate Elixir,
Ferdinal Suspension, Guiaphed Elixir,
Hydroxyzine Compound Syrup,
Iophylline Elixir, Isolate Compound
Elixir, and Theofed Suspension and
Liquid; Warner Lambert Co. (now part
of Pfizer, Inc., 235 East 42nd St., New
York, NY 10017), regarding Tedral SA;
and William P. Poythress & Co., Inc., 16
N. 22nd St., P.O. Box 26946, Richmond,
VA 23261, regarding an unidentified
product containing a xanthine
derivative, ephedrine, and 8 mg or less
of phenobarbital.
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In March and April 2011, FDA sent
letters to Abbott Laboratories, Actavis
US, Mead Johnson Nutrition, and Pfizer,
Inc., requesting that these companies
withdraw or affirm their outstanding
hearing requests under this docket
within 30 days.
On April 25, 2011, Mead Johnson
Nutrition withdrew the hearing request
filed by Mead Johnson Laboratories. On
May 3, 2011, Pfizer, Inc. withdrew the
hearing request filed by Warner Lambert
Co. On May 9, 2011, Actavis US
withdrew the hearing request filed by
National Pharmaceutical Manufacturing
Co. On June 21, 2011, Abbott
Laboratories withdrew the hearing
request filed by Knoll Pharmaceutical
Co.
FDA was unable to find current
contact information for William P.
Poythress & Co. If this company, or its
successor-in-interest, continues to have
an interest in pursuing its hearing
request under this docket, the company
(or its successor-in-interest) must affirm
its hearing request in writing by the date
specified in this notice (see DATES). FDA
will assume that hearing requests that
are not affirmed within that timeframe
are no longer being pursued, and will
deem them withdrawn.
C. Certain Single Entity Antispasmodic
Drugs; Docket No. FDA–1975–N–0355
(Formerly 75N–0185) (DESI 3265)
In 1971, FDA published DESI efficacy
findings for single-ingredient
anticholinergic drugs for oral or
injectable use containing dicyclomine
HCl and piperidolate HCl, among other
ingredients (36 FR 11754, June 18,
1971). In a notice published on
November 11, 1975 (40 FR 52644), FDA
determined that the June 18, 1971,
Federal Register notice should not have
included drugs containing certain
specified ingredients, including
dicyclomine HCl and piperidolate HCl,
because the drugs containing those
ingredients were not anticholinergic
drugs. Also on November 11, 1975, FDA
published a notice of opportunity for
hearing regarding these drugs (40 FR
52649). In response to the November
1975 notice, the following companies
filed timely hearing requests: Carnrick
Laboratories, Inc., 65 Horsehill Rd.,
Cedar Knolls, NJ 07927, regarding
Midrin, and Merrell-National
Laboratories, 110 Amity Rd., Cincinnati,
OH 45215, regarding Bentyl Capsules
(NDA 7–409), Bentyl Injection (NDA 8–
370), Bentyl Syrup (NDA 7–961), and
Dactil Tablets (NDA 8–907).
In September 2011, FDA sent letters
to counsel for Carnrick Laboratories,
Inc., which FDA believed operated as a
subsidiary of Elan Corporation PLC, and
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to Sanofi-Aventis U.S., which FDA
believes to be the successor-in-interest
to Merrell-National Laboratories. In
September 2011, Carnrick Laboratories,
Inc.’s former counsel informed FDA that
it did not represent Carnrick
Laboratories, Inc., or Elan Corporation
PLC with respect to the hearing request
under DESI 3265. In October 2011, FDA
sent a letter to Sun Pharmaceutical
Industries, Inc., believing it to be the
successor-in-interest to Carnrick
Laboratories, Inc.’s hearing request. On
November 3, 2011, a representative from
Sun Pharmaceutical Industries, Inc.,
verbally informed FDA that it was
withdrawing the hearing request filed
by Carnrick Laboratories, Inc., and
stated they would be submitting their
withdrawal of the hearing request in
writing.
As of April 1, 2012, Sanofi-Aventis
U.S. has not responded to FDA. If this
company, or the successor-in-interest,
continues to have an interest in
pursuing the hearing request filed by
Merrell-National Laboratories under this
docket, the company (or its successorin-interest) must affirm the hearing
request in writing by the date specified
in this notice (see DATES). FDA will
assume that hearing requests that are
not affirmed within that timeframe are
no longer being pursued, and will deem
them withdrawn.
D. Certain Anticholinergics/
Antispasmodics in Combination With a
Sedative, and Single-Entity
Antispasmodics, in Conventional
Dosage Form; Docket No. FDA–1975–N–
0336 (Formerly 75N–0184) (DESI 10837)
Through DESI review, FDA
determined that two products,
Pathibamate and Milpath Tablets, both
containing tridihexethyl chloride and
meprobamate, were possibly effective as
adjunctive therapy in peptic ulcer and
in the irritable bowel syndrome,
functional diarrhea, drug-induced
diarrhea, ulcerative colitis, urinary
bladder spasm, and urethral spasm (36
FR 11875, June 22, 1971). In 1981, FDA
reclassified these products to lacking
substantial evidence of effectiveness,
proposed withdrawing associated
NDAs, and offered an opportunity for
hearing regarding its proposal (46 FR
3977, January 16, 1981). In response to
the January 1981 notice, the following
companies filed timely hearing requests:
Cord Laboratories (now part of Sandoz,
Inc., 2555 West Midway Blvd.,
Broomfield, CO 80020), regarding
Chlordinium Capsules (ANDA 86–667);
Roche Laboratories (now part of
Genentech, Inc., 1 DNA Way, South San
Francisco, CA 94080–4990), regarding
Librax; and Premo Pharmaceutical
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Laboratories, Inc. (now part of Teva
Pharmaceuticals, 1090 Horsham Rd.,
P.O. Box 1090, North Wales, PA 19454–
1090), regarding Meprohex 200 (ANDA
86–674), Meprohex 400 (ANDA 86–
658), and chlordinium capsules (ANDA
86–667).
FDA sent letters to Genentech, Inc., in
November 2010, and to Sandoz, Inc.,
and counsel of record for Premo
Pharmaceutical Laboratories, Inc., in
January 2011, requesting that these
companies withdraw or affirm their
outstanding hearing requests under this
docket within 30 days. At the time, FDA
was unable to find a current address for
Premo Pharmaceutical Laboratories,
Inc., and did not know that the
company is part of Teva
Pharmaceuticals.
On February 4, 2011, Genentech, Inc.,
informed FDA that it was no longer
interested in pursuing the hearing
request filed by Roche Laboratories, but
noted that it had sold the rights of the
product that was the subject of the
hearing request to Valeant
Pharmaceuticals International, Inc. On
February 28, 2011, Sandoz, Inc.,
withdrew the hearing request filed by
Cord Laboratories. On March 15, 2011,
Teva Pharmaceuticals withdrew the
hearing request filed by Premo
Pharmaceutical Laboratories, Inc.
In March 2011, FDA sent a letter to
Valeant Pharmaceuticals International,
Inc., requesting that the company
withdraw or affirm the outstanding
hearing request filed by Roche
Laboratories under this docket within
30 days. As of April 1, 2012, Valeant
Pharmaceuticals International, Inc., had
not responded to FDA. If this company,
or its successor-in-interest, continues to
have an interest in pursuing its hearing
request under this docket, the company
(or its successor-in-interest) must affirm
its hearing request in writing by the date
specified in this notice (see DATES). FDA
will assume that hearing requests that
are not affirmed within that timeframe
are no longer being pursued, and will
deem them withdrawn.
E. Chlorthalidone; Docket No. FDA–
1979–N–0224 (Formerly 79N–0169)
(DESI 12283)
In 1979, as part of the DESI review,
FDA announced its conclusions
regarding the effectiveness of
chlorthalidone for the treatment of
hypertension and certain types of edema
(44 FR 54124, September 18, 1979).
Specifically, FDA determined that there
was substantial evidence to support the
effectiveness of the 25- and 50-mg
strengths for use in hypertension, but
that there was no longer justification for
the 100-mg dosage form of
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43341
chlorthalidone because of safety
concerns at that dosage level (id. at
54126). The 1979 notice proposed to
withdraw approval of the 100-mg
strength and offered an opportunity for
hearing regarding its proposal. In
response to the 1979 notice, the
following companies filed timely
hearing requests: Generics International
Division of Apotex, Inc., 2400 North
Commerce Pkwy., suite 400, Weston, FL
33326, regarding Chlorthalidone, and
USV Pharmaceutical Corp. (now part of
Sanofi-Aventis U.S., 55 Corporate Dr.,
Bridgewater, NJ 08807), regarding
Hygroton (NDA 12–283).
FDA sent letters to Sanofi-Aventis
U.S. and Apotex, Inc., in May 2011 and
July 2011, respectively, requesting that
the companies withdraw or affirm their
outstanding hearing requests under this
docket within 30 days.
On August 12, 2011, Sanofi-Aventis
U.S. withdrew the outstanding hearing
request filed by USV Pharmaceutical
Corp. As of April 1, 2012, Apotex, Inc.,
had not responded to FDA. If this
company, or its successor-in-interest,
continues to have an interest in
pursuing its hearing request under this
docket, the company (or its successorin-interest) must affirm its hearing
request in writing by the date specified
in this notice (see DATES). FDA will
assume that hearing requests that are
not affirmed within that timeframe are
no longer being pursued, and will deem
them withdrawn.
F. Chlortetracycline and Tetracycline;
Docket No. FDA–1983–N–0297
(Formerly 83N–0030) (DESI 50213)
Through DESI review, FDA
determined that certain fixedcombination drugs containing
antibiotics and sulfonamides lack
substantial evidence of effectiveness (34
FR 6008, April 2, 1969). The April 1969
Federal Register notice proposed to
revoke provisions for certification of
these products and offered interested
persons 30 days to submit data
concerning the proposal. Data submitted
in response to the April 1969 notice did
not provide substantial evidence of
effectiveness, so FDA amended the
antibiotic regulations on June 30, 1970,
by revoking provisions for the
certification of these drugs (35 FR
10587, June 30, 1970). The order was to
become effective in 40 days, and
allowed 30 days for interested persons
to file objections and request a hearing.
The time for responding to the June
1970 order was subsequently extended
until August 17, 1970 (35 FR 12653,
August 8, 1970).
In response to the June 1970 order,
Pfizer, Inc., submitted data regarding its
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affected product, Urobiotic 250
Capsules, and requested a hearing.
Despite the filing of timely objections,
the amendments were inadvertently not
stayed, and succeeding codifications of
the antibiotic regulations did not
explicitly provide for certification of
Urobiotic 250 Capsules. However, FDA
permitted Pfizer, Inc., to continue
distribution of its product pending
resolution of the firm’s hearing request.
In July 2010, Pfizer, Inc., voluntarily
withdrew its application for Urobiotic
(see 75 FR 42455, July 21, 2010), but its
hearing request remains pending.
In October 2010, FDA sent Pfizer, Inc.,
a letter requesting that it withdraw or
affirm its outstanding hearing request
under this docket within 30 days. As of
April 1, 2012, Pfizer, Inc., had not
responded to FDA. If Pfizer, Inc. (or its
successor-in-interest), continues to have
an interest in pursuing its hearing
request under this docket, the company
(or its successor-in-interest) must affirm
its hearing request in writing by the date
specified in this notice (see DATES). FDA
will assume that hearing requests that
are not affirmed within that timeframe
are no longer being pursued, and will
deem them withdrawn.
G. Hydrocortisone Acetate and
Pramoxine HCl; Docket No. FDA–1988–
N–0004 (Formerly 88N–0242)
Through DESI review, FDA
determined that topical corticosteroids,
including hydrocortisone acetate, were
effective for symptomatic relief and
adjunctive management of various
steroid-responsive dermatoses (36 FR
7982, April 28, 1971). In the mid-1970s,
FDA approved several products under
ANDAs listing hydrocortisone acetate as
their sole active ingredient.
Subsequently, FDA determined that
these products also contained an
anesthetic active ingredient, pramoxine
HCl. FDA evaluated the effectiveness of
the fixed-combination and found no
evidence that the pramoxine HCl
component contributes an effect to the
combination drug (53 FR 25013, July 1,
1988). Thus, FDA proposed to withdraw
the ANDAs for these products and
offered an opportunity for hearing on its
proposal (id).
In response to the July 1988 notice,
the following companies filed timely
hearing requests: Copley
Pharmaceutical, Inc., 398 West Second
St., Boston, MA 02127, regarding a
topical aerosol foam hydrocortisone and
pramoxine HCl product (ANDA 89–
440); Ferndale Laboratories, Inc. (now
part of Ferndale Pharma Group, Inc.,
780 W. Eight Mile Rd., Ferndale, MI
48220), regarding Pramosone lotion
(0.5% hydrocortisone acetate) (ANDA
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83–213), Pramosone cream (0.5%
hydrocortisone acetate) (ANDA 83–778),
Pramosone cream (1.0% hydrocortisone
acetate) (ANDA 85–368), Pramosone
lotion (1.0% hydrocortisone acetate)
(ANDA 85–979), Pramosone lotion
(2.5% hydrocortisone acetate) (ANDA
85–980), Pramosone ointment (1%
hydrocortisone acetate), Pramosone
ointment (2.5% hydrocortisone acetate),
Pramosone cream (2.5% hydrocortisone
acetate), Enzone cream, Zone-A lotion,
Zone-A Forte lotion, Zone-A cream, FEP
cream, Dibucort cream, and Proctocream HC; and Reed & Carnrick (now
part of Meda Pharmaceuticals, Inc., 265
Davidson Ave., suite 300, Somerset, NH
08873–4120), regarding its topical
aerosol foam hydrocortisone and
pramoxine HCl products (ANDAs 86–
195 and 86–457).
In November 2010, FDA sent letters to
Copley Pharmaceutical, Inc.; Ferndale
Pharma Group, Inc.; and Meda
Pharmaceuticals, Inc., requesting that
these companies (or their successors-ininterest) withdraw or affirm their
outstanding hearing requests under this
docket within 30 days. On January 3,
2011, counsel for Ferndale Laboratories,
Inc., and Meda Pharmaceutical, Inc.,
sent a letter affirming the hearing
requests made by both companies.
As of April 1, 2012, Copley
Pharmaceutical, Inc., had not responded
to FDA. If this company (or its
successor-in-interest) continues to have
an interest in pursuing its hearing
request under this docket, the company
(or its successor-in-interest) must affirm
its hearing request in writing by the date
specified in this notice (see DATES). FDA
will assume that hearing requests that
are not affirmed within that timeframe
are no longer being pursued, and will
deem them withdrawn.
This notice is issued under the
Federal Food, Drug, and Cosmetic Act
(sections 502 and 505 (21 U.S.C. 352
and 355)).
Dated: July 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–18015 Filed 7–23–12; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice Regarding Section 340B of the
Public Health Service Act Registration
Period
Department of Health and
Human Services, Health Resources and
Services Administration.
ACTION: Notice.
AGENCY:
The Health Resources and
Services Administration (HRSA) is
issuing this notice to inform
stakeholders of the revised deadlines for
registration of new covered entities and
for adding outpatient facilities and
contract pharmacy arrangements to the
340B Drug Pricing Program (340B
Program).
SUMMARY:
Effective Date: October 1, 2012.
CDR
Krista Pedley, Director, OPA, HSB,
HRSA, 5600 Fishers Lane, Parklawn
Building, Room 10C–03, Rockville, MD
20857, or by telephone at 301–594–
4353.
DATES:
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Background
Section 340B(a)(4) of the Public
Health Service Act (PHS) Act (42 U.S.C.
256b) lists the various types of
organizations eligible to participate in
and purchase discounted drugs under
the 340B Program. For a complete list of
eligible entities, visit the OPA Web site
at https://www.hrsa.gov/
opa.introduction.htm. Eligibility for
participation in the 340B Program is
limited to the categories of entities
specified in this section of the statute.
Section 340B(a)(9) of the PHS Act
requires the Secretary to notify
participating manufacturers of the
identity of those entities that meet the
definition of covered entity under
340B(a)(4). HRSA published final
guidelines on the participation of
outpatient facilities in the Federal
Register at 59 FR 47884 (Sept. 19, 1994).
HRSA published final guidelines on the
utilization of Contract Pharmacy
Arrangements in the Federal Register at
75 FR 10272 (March 5, 2010).
II. Registration Deadlines
This notice replaces all previous 340B
Program guidance documents
addressing the deadline and enrollment
period for the 340B Program registration
of new covered entities, addition of
outpatient facilities and contract
pharmacies, including any individual
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]]>Agencies
[Federal Register Volume 77, Number 142 (Tuesday, July 24, 2012)]
[Notices]
[Pages 43337-43342]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18015]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-1975-N-0336 (Formerly 75N-0184), FDA-1975-N-0355
(Formerly 75N-0185), FDA-1976-N-0272 (Formerly 76N-0056), FDA-1976-N-
0344 (Formerly 76N-0057), FDA-1978-N-0701 (Formerly 78N-0070), FDA-
1979-N-0224 (Formerly 79N-0169), FDA-1983-N-0297 (Formerly 83N-0030),
and FDA-1988-N-0004 (Formerly 88N-0242); DESI 597, 1626, 3265, 10837,
12283, and 50213, and Hydrocortisone Acetate and Pramoxine
Hydrochloride]
Drugs for Human Use; Drug Efficacy Study Implementation; Certain
Prescription Drugs Offered for Various Indications; Opportunity To
Affirm Outstanding Hearing Request
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is offering an
opportunity to affirm outstanding hearing requests pertaining to
several dockets. FDA will assume that companies with outstanding
hearing requests that do not respond to this notice are no longer
interested in pursuing their requests, and will deem the requests
withdrawn.
DATES: Effective Date: This notice is effective August 23, 2012.
Hearing Requests: Hearing requests must be affirmed by notifying
FDA by August 23, 2012. Hearing requests not affirmed within that
timeframe will be deemed withdrawn.
ADDRESSES: Requests to affirm or withdraw outstanding hearing requests,
as well as all other communications in response to this notice, should
be identified with the appropriate docket number, and directed to
Pamela Lee, Office of Unapproved Drugs and Labeling Compliance, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm. 5173, Silver Spring, MD 20993-0002.
[[Page 43338]]
FOR FURTHER INFORMATION CONTACT: Pamela Lee, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, rm. 5173, Silver Spring, MD 20993-0002, 301-796-3297, email:
pamela.lee@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA) is
offering an opportunity to affirm outstanding hearing requests
pertaining to FDA Docket Nos. FDA-1975-N-0336 (formerly 75N-0184) (DESI
597); FDA-1976-N-0272 (formerly 76N-0056), FDA-1976-N-0344 (formerly
76N-0057), and FDA-1978-N-0701 (formerly 78N-0070) (DESI 1626); FDA-
1975-N-0355 (formerly 75N-0185) (DESI 3265); FDA-1975-N-0336 (formerly
75N-0184) (DESI 10837); FDA-1979-N-0224 (formerly 79N-0169) (DESI
12283); FDA-1983-N-0297 (formerly 83N-0030) (DESI 50213); and FDA-1988-
N-0004 (formerly 88N-0242).
I. Background
When initially enacted in 1938, the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) required that ``new drugs'' (see 21 U.S.C.
321(p)) be approved for safety by FDA before they could legally be sold
in interstate commerce. To this end, the FD&C Act made it the sponsor's
responsibility, before marketing a new drug, to submit a new drug
application (NDA) to FDA to prove that its drug was safe. Between 1938
and 1962, if a drug obtained approval, FDA considered drugs that were
identical, related, or similar (IRS) (see (21 CFR 310.6(b)(1)) to the
approved drug to be ``covered'' by that approval, and allowed those IRS
drugs to be marketed without independent approval.
In 1962, Congress amended the FD&C Act to require that new drugs be
proven effective for their labeled indications, as well as safe, to
obtain FDA approval. This amendment also necessitated that FDA conduct
a retrospective evaluation of the effectiveness of the drug products
that FDA had approved as safe between 1938 and 1962. FDA contracted
with the National Academy of Sciences/National Research Council (NAS/
NRC) to make an initial evaluation of the effectiveness of over 3,400
products that had been approved only for safety between 1938 and 1962.
The NAS/NRC reports for these drug products were submitted to FDA in
the late 1960s and early 1970s. The Agency reviewed and reevaluated the
reports and published its findings in Federal Register notices. FDA's
administrative implementation of the NAS/NRC reports was called the
Drug Efficacy Study Implementation (DESI). DESI covered the
approximately 3,400 products specifically reviewed by the NAS/NRC, as
well as the even larger number of IRS products that entered the market
without FDA approval.
All drugs covered by the DESI review are ``new drugs'' under the
FD&C Act. If FDA's final DESI determination classifies a drug product
as lacking substantial evidence of effectiveness for one or more
indications, that drug product and those IRS to it may no longer be
marketed for the indications and are subject to enforcement action as
unapproved new drugs. If FDA's final DESI determination classifies the
drug product as effective for one or more of its labeled indications,
the drug can be marketed for those indications, provided it is the
subject of an application approved for safety and effectiveness.
Sponsors of drug products that have been found to be effective for one
or more indications through the DESI process may rely on FDA's
effectiveness determinations, but typically must update their labeling
to conform to the indications found to be effective by FDA and to
include any additional safety information required by FDA. Those drug
products with NDAs approved before 1962 for safety therefore require
approved supplements to their original applications if found to be
effective under DESI; IRS drug products require an approved NDA or
abbreviated new drug application (ANDA), as appropriate. Furthermore,
labeling for drug products classified as effective may contain only
those indications for which the review found the product effective
unless the firm marketing the product has received an approval for the
additional indication(s).
II. Outstanding Hearing Requests Pertaining to Docket Nos. FDA-1975-N-
0336 (Formerly 75N-0184) (DESI 597); FDA-1976-N-0272 (Formerly 76N-
0056), FDA-1976-N-0344 (Formerly 76N-0057), and FDA-1978-N-0701
(Formerly 78N-0070) (DESI 1626); FDA-1975-N-0355 (Formerly 75N-0185)
(DESI 3265); FDA-1975-N-0336 (Formerly 75N-0184) (DESI 10837); FDA-
1979-N-0224 (Formerly 79N-0169) (DESI 12283); FDA-1983-N-0297 (Formerly
83N-0030) (DESI 50213); and FDA-1988-N-0004 (Formerly 88N-0242)
In 2006, FDA announced a new drug safety initiative to address
unapproved drugs currently being marketed in the United States, and to
facilitate a rational process to bring all such unapproved drugs into
the approval process. As part of the Unapproved Drugs Initiative, the
Office of Compliance of the Center for Drug Evaluation and Research is
reviewing proceedings that remain open under DESI. According to FDA's
records, the dockets discussed in this document contain pending hearing
requests.
This Federal Register notice identifies the products that are the
subjects of hearing requests to the extent possible based on the
information contained in the hearing requests. In some cases, the
companies requesting hearings identified the product that was the
subject of the hearing request by name. In other cases, the company
simply identified the subject of its hearing request as a product that
is IRS to one of the products reviewed under DESI. In yet other cases,
there is no information provided by the requester about the product
that is the subject of its hearing request.
In cases where FDA was able to obtain current contact information
for a company (or its successor-in-interest) or its representative, FDA
sent letters directly to the companies (or their successors-in-
interest) and/or their representatives requesting that outstanding
hearing requests be withdrawn or affirmed within a specified timeframe.
In some cases, however, FDA was unable to find current contact
information for the companies that requested hearings. Because many of
the products that are the subjects of these hearing requests may no
longer be marketed and some of the companies that requested hearings
may no longer be in business, FDA is seeking to determine whether there
is continued interest in pursuing these outstanding hearing requests.
It should be noted that the discussion of DESI dockets does not provide
a comprehensive historical record of each docket and, therefore, will
not identify every request that had been previously addressed.
Through this Federal Register notice, FDA seeks to have any company
with an outstanding hearing request covered by this notice that has not
already responded to a direct communication from FDA either withdraw or
affirm its hearing request. FDA will assume that companies with
outstanding hearing requests that do not respond to this notice are no
longer in business and/or do not have a continuing interest in the
hearings, and FDA will deem their requests withdrawn.
To withdraw an outstanding hearing request, a company (or its
successor-in-interest) or its representative should send a letter
stating its intention to do so to Pamela Lee (see ADDRESSES). The
letter should include the docket number of the proceeding, as well as
the name
[[Page 43339]]
and National Drug Code (NDC) number of the product that is the subject
of the hearing request.
To affirm an outstanding hearing request, a company (or its
successor-in-interest) or its representative should send a letter
stating its intention to do so to Pamela Lee (see ADDRESSES). The
letter should include the docket number of the proceeding, as well as
the name and NDC number of the product that is the subject of the
hearing request. Letters affirming outstanding hearing requests must be
postmarked or emailed by the date specified in this notice (see DATES).
Only currently outstanding hearing requests may be affirmed; this
notice does not provide a new opportunity to request a hearing under
any of these dockets.
A. Certain Drug Products Containing an Anticholinergic in Combination
With a Barbituate; Docket No. FDA-1975-N-0336 (Formerly 75N-0184) (DESI
597)
Under Docket No. FDA-1975-N-0336 (formerly 75N-0184), FDA
determined that certain drug products containing an anticholinergic in
combination with a barbiturate lacked substantial evidence of
effectiveness for various gastrointestinal disorders, and offered an
opportunity for hearing regarding its conclusion (48 FR 20495, May 6,
1983). In response to the May 1983 notice, the following companies
filed timely hearing requests: A.H. Robins Co. (now part of Pfizer,
Inc., 235 East 42nd St., New York, NY 10017), regarding Donnatal
Tablets (ANDA 86-676), Capsules (ANDA 86-677), and Elixir (ANDA 86-
661); B.F. Ascher & Co., Inc., 15501 W. 109th St., Lenexa, KS 66219,
regarding Anaspaz-PB; Bay Laboratories, Inc., 3654 West Jarvis, Skokie,
IL 60076, regarding Bay-Ase Elixir (ANDA 86-673); Beecham Laboratories,
a Division of Beecham, Inc. (now part of Glaxo SmithKline, 200 N 16th
St., 1, Philadelphia, PA 19102), regarding Hybephen (ANDA 86-
573); Carter-Wallace, Inc. (now part of Meda Pharmaceuticals, Inc., 265
Davidson Ave., Suite 300, Somerset, NJ 08873-4120), regarding
Barbidonna Tablets (ANDA 86-589), Barbidonna Elixir (ANDA 86-590), and
Barbidonna No. 2 Tablets (ANDA 87-572); Ferndale Laboratories, Inc.
(now part of Ferndale Pharma Group, Inc., 780 W. Eight Mile Rd.,
Ferndale, MI 48220), regarding Bellkatal Tablets and Pheno-Bella
Tablets; Halsey Drug Co., Inc. (now part of Acura Pharmaceuticals,
Inc., 616 N. North Court, Suite 120, Palatine, IL 60067), regarding
Susano Elixir (ANDA 86-587) and Susano Tablets (ANDA 86-588); Kremers-
Urban Co. (now part of Kremers-Urban Pharmaceuticals, Inc., 902
Carnegie Center, Suite 360, Princeton, NJ 08540), regarding Levsin with
Phenobarbital Tablets (ANDA 86-640); Lemmon Co. (now part of Teva
Pharmaceuticals, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA
19454-1090), regarding Belladonna Alkaloids and Phenobarbital Tablets
(ANDA 86-591); McNeil Pharmaceutical (now part of Ortho-McNeil-Janssen
Pharmaceuticals, Inc., 1125 Trenton-Harbourton Rd., P.O. Box 200,
Titusville, NJ 08568), regarding Butibel Tablets and Butibel Elixir
(ANDA 86-664); National Pharmaceutical Manufacturing Co. (now part of
Actavis US, 60 Columbia Rd., Bldg. B, Morristown, NJ 07960), regarding
Barophen Elixir (ANDA 86-546) and Butabar Belladonna Elixir (ANDA 86-
561); Purepac Pharmaceutical (now part of Actavis US, 60 Columbia Rd.,
Bldg. B, Morristown, NJ 07960), regarding Belladonna Alkaloids with
Phenobarbital Tablets and Elixir; Reid-Provident Laboratories, Inc.
(now part of Abbott Laboratories, 100 Abbott Park Rd., Abbott Park, IL
60064-3500), regarding Spalix Elixir (ANDA 86-652) and Spalix Tablets
(ANDA 86-653); Richlyn Laboratories, Inc. (now part of Impax
Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544), regarding
Bellophen (ANDA 86-687) and Spasmolin (ANDA 86-655); Sandoz, Inc., 506
Carnegie Center, Suite 400, Princeton, NJ 08540, regarding Belladenal
Tablets (ANDA 86-668) and Belladenal S Tablets (ANDA 87-198); Stuart
Pharmaceuticals, Division of ICI Americas, Inc. (now part of
AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, P.O. Box 15437,
Wilmington, DE 19850-5437), regarding Kinesed Tablets; Vale Chemical
Co., Inc., 1201 Liberty St., Allentown, PA 18102, regarding Barbeloid
Tablets, Green (NDA 85-532) and Barbeloid Tablets, Yellow (NDA 86-549);
West-ward Pharmaceutical Corp., 401 Industrial Way West, Eatontown, NJ
07724-2206, regarding Belladonna Alkaloid with Phenobarbital Tablets;
William P. Poythress & Co., Inc., 16 N. 22nd St., P.O. Box 26946,
Richmond, VA 23261, regarding unidentified products composed of
atropine sulfate 0.195 milligrams (mg) in combination with
phenobarbital 16 mg; William Rorer, Inc. (now part of Sanofi-Aventis
U.S., 55 Corporate Dr., Bridgewater, NJ 08807), regarding Chardonna-2
Tablets (ANDA 86-585); and Wharton Laboratories, Inc., 48th Ave., Long
Island City, NY 11101, regarding Bellastal Capsules (ANDA 86-657).
In May, June, and July 2011, FDA sent letters to the following
companies requesting that they withdraw or affirm their outstanding
hearing requests under this docket within 30 days: Pfizer, Inc.; B.F.
Ascher & Co., Inc.; Glaxo SmithKline; Meda Pharmaceuticals, Inc.;
Ferndale Pharma Group, Inc.; Acura Pharmaceutical Co.; Kremers-Urban
Pharmaceuticals, Inc.; Teva Pharmaceuticals; Ortho-McNeil-Janssen
Pharmaceuticals, Inc.; Actavis US; Abbott Laboratories; Impax
Laboratories, Inc.; Sandoz, Inc.; AstraZeneca Pharmaceuticals LP; West-
ward Pharmaceutical Corp.; and Sanofi-Aventis U.S.
On May 24, 2011, Actavis US withdrew the hearing request filed by
National Pharmaceutical Manufacturing Co. On May 26, 2011, Teva
Pharmaceuticals and Impax Laboratories, Inc., withdrew the hearing
requests filed by Lemmon Co. and Richlyn Laboratories, Inc.,
respectively. On June 2, 2011, Ferndale Pharma Group, Inc., withdrew
its hearing request. On June 3, 2011, AstraZeneca Pharmaceuticals, LP,
withdrew the hearing request filed by Stuart Pharmaceuticals. On June
6, 2011, Acura Pharmaceutical Co. withdrew the hearing request filed by
Halsey Drug Co., Inc. On June 7, 2011, Johnson & Johnson Pharmaceutical
Research & Development, LLC, responded to the letter sent to Ortho-
McNeil-Janssen Pharmaceuticals, Inc., stating that the rights to
Butibel Elixir had been transferred to Carter Wallace in 1982. On June
20, 2011, B.F. Ascher & Co., Inc., withdrew its hearing request. On
June 22, 2011, Novartis Pharmaceuticals Corp., the successor-in-
interest by merger to Sandoz, Inc., withdrew Sandoz, Inc.'s hearing
request. On July 7, 2011, Meda Pharmaceuticals, Inc., withdrew the
hearing request filed by Carter-Wallace, Inc., as well as the hearing
request filed by McNeil Pharmaceutical for Butibel Tablets and Elixir.
On July 27, 2011, Kremers-Urban Co. withdrew its hearing request. On
August 11, 2011, GlaxoSmithKline withdrew the hearing request filed by
Beecham Laboratories. On August 24, 2011, Abbott Laboratories withdrew
the hearing request filed by Reid-Provident Laboratories, Inc.
On July 6, 2011, West-ward Pharmaceutical Corp. affirmed its
hearing request and PBM Pharmaceuticals, Inc., affirmed the hearing
request filed by A.H. Robins Co., as the asserted successor-in-interest
to A.H. Robins Co.'s hearing request. A Federal Register notice issued
on June 8, 2011 (76 FR 33310), withdrew the approval of 70 NDAs and 97
ANDAs. This included the withdrawal of the approval for Donnatal
Capsules and
[[Page 43340]]
withdrawal of the conditional approval for the Donnatal Tablets and
Elixir. This withdrawal notice was subsequently corrected to note that
the approval and conditional approvals for these products were still in
effect, because PBM Pharmaceuticals, Inc., had acquired the rights to
the ANDAs and had informed FDA before the withdrawal would have become
effective that it did not want the ANDAs withdrawn (76 FR 79701,
December 22, 2011).
As of April 1, 2012, Actavis U.S. (with respect to the hearing
request filed by Purepac Pharmaceutical) and Sanofi-Aventis U.S. had
not responded to FDA. FDA was unable to find current contact
information for Bay Laboratories, Inc.; Vale Chemical Co., Inc.;
William P. Poythress & Co., Inc.; and Wharton Laboratories, Inc. If any
of these companies, or any successor-in-interest, continues to have an
interest in pursuing its hearing request under this docket, the
companies (or their successors-in-interest) must affirm their hearing
requests in writing by the date specified in this notice (see DATES).
FDA will assume that hearing requests that are not affirmed within that
timeframe are no longer being pursued, and will deem them withdrawn.
B. Combination Drugs Containing a Xanthine Derivative; Docket No. FDA-
1976-N-0272 (Formerly 76N-0056), FDA-1976-N-0344 (Formerly 76N-0057),
and FDA-1978-N-0701 (Formerly 78N-0070) (DESI 1626)
In 1972, FDA classified certain combination drug products
containing a xanthine derivative as less than effective for some
labeled indications and possibly effective for other labeled
indications (37 FR 14895, July 26, 1972). As described in a Federal
Register notice of February 29, 1984, FDA subsequently handled these
products in three groups: (1) Combinations containing more than 2
grains of xanthine derivative, more than 8 mg of phenobarbital, and/or
an ingredient not considered as part of the over-the-counter (OTC) drug
review (Docket No. FDA-1976-N-0272 (formerly 76N-0056)); (2)
combinations containing 2 grains or less of a xanthine derivative,
ephedrine, and 8 mg or less of phenobarbital (Docket No. FDA-1976-N-
0344 (formerly 76N-0057)); and (3) combinations containing
theophylline, ephedrine, and hydroxyzine hydrochloride (HCl) (Docket
No. FDA-1978-N-0701 (formerly 78N-0070)) (49 FR 7454, February 29,
1984).
In 1976, FDA reclassified certain combination preparations
containing a xanthine derivative to lacking substantial evidence of
effectiveness, proposed withdrawing associated NDAs, and offered an
opportunity for hearing regarding its proposal (41 FR 15051, April 9,
1976). The group of products addressed in the April 1976 notice
contained more than 2 grains of xanthine derivative, a barbiturate in
higher strength than the equivalent of 8 mg of phenobarbital, and/or an
ingredient not considered as part of the OTC drug review (Docket No.
FDA-1976-N-0272 (formerly 76N-0056)) (id.). The holders of the NDAs
listed in the April 1976 notice did not request hearings, and those
NDAs were withdrawn in October 1977 (42 FR 54620, October 7, 1977).
However, in response to the April 1976 notice, the following companies
filed timely hearing requests: Knoll Pharmaceutical Co. (now part of
Abbott Laboratories, 100 Abbott Park Rd., Abbott Park, IL 60064-3500),
regarding Quadrinal Tablets and Suspension, and Mead Johnson
Laboratories (now Mead Johnson Nutrition, 4th Floor, 2701 Patriot
Blvd., Glenview, IL 60026), regarding Quibron Plus Capsules and Elixir.
In 1984, FDA amended the April 1976 notice to include its analysis
of new information regarding combination products containing a xanthine
derivative (49 FR 7454, February 29, 1984). Based on its analysis of
the new information, FDA concluded that there is a lack of substantial
evidence that: (1) Each ingredient contributes to the claimed effect of
such combination drug products, and (2) the dosage of each component is
such that the combinations are safe and effective for a significant
patient population (id.). Therefore, FDA proposed in the 1984 notice to
withdraw approval of the applications for combination products
containing a xandine derivative, and offered an opportunity for hearing
regarding its proposal. In response to the February 1984 notice, the
following companies filed timely hearing requests: National
Pharmaceutical Manufacturing Co. (now part of Actavis US, 60 Columbia
Rd., Bldg. B, Morristown, NJ 07960), regarding Brondelate Elixir,
Ferdinal Suspension, Guiaphed Elixir, Hydroxyzine Compound Syrup,
Iophylline Elixir, Isolate Compound Elixir, and Theofed Suspension and
Liquid; Warner Lambert Co. (now part of Pfizer, Inc., 235 East 42nd
St., New York, NY 10017), regarding Tedral SA; and William P. Poythress
& Co., Inc., 16 N. 22nd St., P.O. Box 26946, Richmond, VA 23261,
regarding an unidentified product containing a xanthine derivative,
ephedrine, and 8 mg or less of phenobarbital.
In March and April 2011, FDA sent letters to Abbott Laboratories,
Actavis US, Mead Johnson Nutrition, and Pfizer, Inc., requesting that
these companies withdraw or affirm their outstanding hearing requests
under this docket within 30 days.
On April 25, 2011, Mead Johnson Nutrition withdrew the hearing
request filed by Mead Johnson Laboratories. On May 3, 2011, Pfizer,
Inc. withdrew the hearing request filed by Warner Lambert Co. On May 9,
2011, Actavis US withdrew the hearing request filed by National
Pharmaceutical Manufacturing Co. On June 21, 2011, Abbott Laboratories
withdrew the hearing request filed by Knoll Pharmaceutical Co.
FDA was unable to find current contact information for William P.
Poythress & Co. If this company, or its successor-in-interest,
continues to have an interest in pursuing its hearing request under
this docket, the company (or its successor-in-interest) must affirm its
hearing request in writing by the date specified in this notice (see
DATES). FDA will assume that hearing requests that are not affirmed
within that timeframe are no longer being pursued, and will deem them
withdrawn.
C. Certain Single Entity Antispasmodic Drugs; Docket No. FDA-1975-N-
0355 (Formerly 75N-0185) (DESI 3265)
In 1971, FDA published DESI efficacy findings for single-ingredient
anticholinergic drugs for oral or injectable use containing dicyclomine
HCl and piperidolate HCl, among other ingredients (36 FR 11754, June
18, 1971). In a notice published on November 11, 1975 (40 FR 52644),
FDA determined that the June 18, 1971, Federal Register notice should
not have included drugs containing certain specified ingredients,
including dicyclomine HCl and piperidolate HCl, because the drugs
containing those ingredients were not anticholinergic drugs. Also on
November 11, 1975, FDA published a notice of opportunity for hearing
regarding these drugs (40 FR 52649). In response to the November 1975
notice, the following companies filed timely hearing requests: Carnrick
Laboratories, Inc., 65 Horsehill Rd., Cedar Knolls, NJ 07927, regarding
Midrin, and Merrell-National Laboratories, 110 Amity Rd., Cincinnati,
OH 45215, regarding Bentyl Capsules (NDA 7-409), Bentyl Injection (NDA
8-370), Bentyl Syrup (NDA 7-961), and Dactil Tablets (NDA 8-907).
In September 2011, FDA sent letters to counsel for Carnrick
Laboratories, Inc., which FDA believed operated as a subsidiary of Elan
Corporation PLC, and
[[Page 43341]]
to Sanofi-Aventis U.S., which FDA believes to be the successor-in-
interest to Merrell-National Laboratories. In September 2011, Carnrick
Laboratories, Inc.'s former counsel informed FDA that it did not
represent Carnrick Laboratories, Inc., or Elan Corporation PLC with
respect to the hearing request under DESI 3265. In October 2011, FDA
sent a letter to Sun Pharmaceutical Industries, Inc., believing it to
be the successor-in-interest to Carnrick Laboratories, Inc.'s hearing
request. On November 3, 2011, a representative from Sun Pharmaceutical
Industries, Inc., verbally informed FDA that it was withdrawing the
hearing request filed by Carnrick Laboratories, Inc., and stated they
would be submitting their withdrawal of the hearing request in writing.
As of April 1, 2012, Sanofi-Aventis U.S. has not responded to FDA.
If this company, or the successor-in-interest, continues to have an
interest in pursuing the hearing request filed by Merrell-National
Laboratories under this docket, the company (or its successor-in-
interest) must affirm the hearing request in writing by the date
specified in this notice (see DATES). FDA will assume that hearing
requests that are not affirmed within that timeframe are no longer
being pursued, and will deem them withdrawn.
D. Certain Anticholinergics/Antispasmodics in Combination With a
Sedative, and Single-Entity Antispasmodics, in Conventional Dosage
Form; Docket No. FDA-1975-N-0336 (Formerly 75N-0184) (DESI 10837)
Through DESI review, FDA determined that two products, Pathibamate
and Milpath Tablets, both containing tridihexethyl chloride and
meprobamate, were possibly effective as adjunctive therapy in peptic
ulcer and in the irritable bowel syndrome, functional diarrhea, drug-
induced diarrhea, ulcerative colitis, urinary bladder spasm, and
urethral spasm (36 FR 11875, June 22, 1971). In 1981, FDA reclassified
these products to lacking substantial evidence of effectiveness,
proposed withdrawing associated NDAs, and offered an opportunity for
hearing regarding its proposal (46 FR 3977, January 16, 1981). In
response to the January 1981 notice, the following companies filed
timely hearing requests: Cord Laboratories (now part of Sandoz, Inc.,
2555 West Midway Blvd., Broomfield, CO 80020), regarding Chlordinium
Capsules (ANDA 86-667); Roche Laboratories (now part of Genentech,
Inc., 1 DNA Way, South San Francisco, CA 94080-4990), regarding Librax;
and Premo Pharmaceutical Laboratories, Inc. (now part of Teva
Pharmaceuticals, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA
19454-1090), regarding Meprohex 200 (ANDA 86-674), Meprohex 400 (ANDA
86-658), and chlordinium capsules (ANDA 86-667).
FDA sent letters to Genentech, Inc., in November 2010, and to
Sandoz, Inc., and counsel of record for Premo Pharmaceutical
Laboratories, Inc., in January 2011, requesting that these companies
withdraw or affirm their outstanding hearing requests under this docket
within 30 days. At the time, FDA was unable to find a current address
for Premo Pharmaceutical Laboratories, Inc., and did not know that the
company is part of Teva Pharmaceuticals.
On February 4, 2011, Genentech, Inc., informed FDA that it was no
longer interested in pursuing the hearing request filed by Roche
Laboratories, but noted that it had sold the rights of the product that
was the subject of the hearing request to Valeant Pharmaceuticals
International, Inc. On February 28, 2011, Sandoz, Inc., withdrew the
hearing request filed by Cord Laboratories. On March 15, 2011, Teva
Pharmaceuticals withdrew the hearing request filed by Premo
Pharmaceutical Laboratories, Inc.
In March 2011, FDA sent a letter to Valeant Pharmaceuticals
International, Inc., requesting that the company withdraw or affirm the
outstanding hearing request filed by Roche Laboratories under this
docket within 30 days. As of April 1, 2012, Valeant Pharmaceuticals
International, Inc., had not responded to FDA. If this company, or its
successor-in-interest, continues to have an interest in pursuing its
hearing request under this docket, the company (or its successor-in-
interest) must affirm its hearing request in writing by the date
specified in this notice (see DATES). FDA will assume that hearing
requests that are not affirmed within that timeframe are no longer
being pursued, and will deem them withdrawn.
E. Chlorthalidone; Docket No. FDA-1979-N-0224 (Formerly 79N-0169) (DESI
12283)
In 1979, as part of the DESI review, FDA announced its conclusions
regarding the effectiveness of chlorthalidone for the treatment of
hypertension and certain types of edema (44 FR 54124, September 18,
1979). Specifically, FDA determined that there was substantial evidence
to support the effectiveness of the 25- and 50-mg strengths for use in
hypertension, but that there was no longer justification for the 100-mg
dosage form of chlorthalidone because of safety concerns at that dosage
level (id. at 54126). The 1979 notice proposed to withdraw approval of
the 100-mg strength and offered an opportunity for hearing regarding
its proposal. In response to the 1979 notice, the following companies
filed timely hearing requests: Generics International Division of
Apotex, Inc., 2400 North Commerce Pkwy., suite 400, Weston, FL 33326,
regarding Chlorthalidone, and USV Pharmaceutical Corp. (now part of
Sanofi-Aventis U.S., 55 Corporate Dr., Bridgewater, NJ 08807),
regarding Hygroton (NDA 12-283).
FDA sent letters to Sanofi-Aventis U.S. and Apotex, Inc., in May
2011 and July 2011, respectively, requesting that the companies
withdraw or affirm their outstanding hearing requests under this docket
within 30 days.
On August 12, 2011, Sanofi-Aventis U.S. withdrew the outstanding
hearing request filed by USV Pharmaceutical Corp. As of April 1, 2012,
Apotex, Inc., had not responded to FDA. If this company, or its
successor-in-interest, continues to have an interest in pursuing its
hearing request under this docket, the company (or its successor-in-
interest) must affirm its hearing request in writing by the date
specified in this notice (see DATES). FDA will assume that hearing
requests that are not affirmed within that timeframe are no longer
being pursued, and will deem them withdrawn.
F. Chlortetracycline and Tetracycline; Docket No. FDA-1983-N-0297
(Formerly 83N-0030) (DESI 50213)
Through DESI review, FDA determined that certain fixed-combination
drugs containing antibiotics and sulfonamides lack substantial evidence
of effectiveness (34 FR 6008, April 2, 1969). The April 1969 Federal
Register notice proposed to revoke provisions for certification of
these products and offered interested persons 30 days to submit data
concerning the proposal. Data submitted in response to the April 1969
notice did not provide substantial evidence of effectiveness, so FDA
amended the antibiotic regulations on June 30, 1970, by revoking
provisions for the certification of these drugs (35 FR 10587, June 30,
1970). The order was to become effective in 40 days, and allowed 30
days for interested persons to file objections and request a hearing.
The time for responding to the June 1970 order was subsequently
extended until August 17, 1970 (35 FR 12653, August 8, 1970).
In response to the June 1970 order, Pfizer, Inc., submitted data
regarding its
[[Page 43342]]
affected product, Urobiotic 250 Capsules, and requested a hearing.
Despite the filing of timely objections, the amendments were
inadvertently not stayed, and succeeding codifications of the
antibiotic regulations did not explicitly provide for certification of
Urobiotic 250 Capsules. However, FDA permitted Pfizer, Inc., to
continue distribution of its product pending resolution of the firm's
hearing request. In July 2010, Pfizer, Inc., voluntarily withdrew its
application for Urobiotic (see 75 FR 42455, July 21, 2010), but its
hearing request remains pending.
In October 2010, FDA sent Pfizer, Inc., a letter requesting that it
withdraw or affirm its outstanding hearing request under this docket
within 30 days. As of April 1, 2012, Pfizer, Inc., had not responded to
FDA. If Pfizer, Inc. (or its successor-in-interest), continues to have
an interest in pursuing its hearing request under this docket, the
company (or its successor-in-interest) must affirm its hearing request
in writing by the date specified in this notice (see DATES). FDA will
assume that hearing requests that are not affirmed within that
timeframe are no longer being pursued, and will deem them withdrawn.
G. Hydrocortisone Acetate and Pramoxine HCl; Docket No. FDA-1988-N-0004
(Formerly 88N-0242)
Through DESI review, FDA determined that topical corticosteroids,
including hydrocortisone acetate, were effective for symptomatic relief
and adjunctive management of various steroid-responsive dermatoses (36
FR 7982, April 28, 1971). In the mid-1970s, FDA approved several
products under ANDAs listing hydrocortisone acetate as their sole
active ingredient. Subsequently, FDA determined that these products
also contained an anesthetic active ingredient, pramoxine HCl. FDA
evaluated the effectiveness of the fixed-combination and found no
evidence that the pramoxine HCl component contributes an effect to the
combination drug (53 FR 25013, July 1, 1988). Thus, FDA proposed to
withdraw the ANDAs for these products and offered an opportunity for
hearing on its proposal (id).
In response to the July 1988 notice, the following companies filed
timely hearing requests: Copley Pharmaceutical, Inc., 398 West Second
St., Boston, MA 02127, regarding a topical aerosol foam hydrocortisone
and pramoxine HCl product (ANDA 89-440); Ferndale Laboratories, Inc.
(now part of Ferndale Pharma Group, Inc., 780 W. Eight Mile Rd.,
Ferndale, MI 48220), regarding Pramosone lotion (0.5% hydrocortisone
acetate) (ANDA 83-213), Pramosone cream (0.5% hydrocortisone acetate)
(ANDA 83-778), Pramosone cream (1.0% hydrocortisone acetate) (ANDA 85-
368), Pramosone lotion (1.0% hydrocortisone acetate) (ANDA 85-979),
Pramosone lotion (2.5% hydrocortisone acetate) (ANDA 85-980), Pramosone
ointment (1% hydrocortisone acetate), Pramosone ointment (2.5%
hydrocortisone acetate), Pramosone cream (2.5% hydrocortisone acetate),
Enzone cream, Zone-A lotion, Zone-A Forte lotion, Zone-A cream, FEP
cream, Dibucort cream, and Procto-cream HC; and Reed & Carnrick (now
part of Meda Pharmaceuticals, Inc., 265 Davidson Ave., suite 300,
Somerset, NH 08873-4120), regarding its topical aerosol foam
hydrocortisone and pramoxine HCl products (ANDAs 86-195 and 86-457).
In November 2010, FDA sent letters to Copley Pharmaceutical, Inc.;
Ferndale Pharma Group, Inc.; and Meda Pharmaceuticals, Inc., requesting
that these companies (or their successors-in-interest) withdraw or
affirm their outstanding hearing requests under this docket within 30
days. On January 3, 2011, counsel for Ferndale Laboratories, Inc., and
Meda Pharmaceutical, Inc., sent a letter affirming the hearing requests
made by both companies.
As of April 1, 2012, Copley Pharmaceutical, Inc., had not responded
to FDA. If this company (or its successor-in-interest) continues to
have an interest in pursuing its hearing request under this docket, the
company (or its successor-in-interest) must affirm its hearing request
in writing by the date specified in this notice (see DATES). FDA will
assume that hearing requests that are not affirmed within that
timeframe are no longer being pursued, and will deem them withdrawn.
This notice is issued under the Federal Food, Drug, and Cosmetic
Act (sections 502 and 505 (21 U.S.C. 352 and 355)).
Dated: July 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18015 Filed 7-23-12; 8:45 am]
BILLING CODE 4160-01-P
