Determination That TESSALON (Benzonatate) Capsules and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 42828-42829 [2015-17730]
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42828
Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices
Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
meet relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2015–17729 Filed 7–17–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2412]
Determination That TESSALON
(Benzonatate) Capsules and Other
Drug Products Were Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that the drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
SUMMARY:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6207, Silver Spring,
MD 20993–0002, 301–796–8363.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
sponsors must, with certain exceptions,
show that the drug for which they are
seeking approval contains the same
active ingredient in the same strength
and dosage form as the ‘‘listed drug,’’
which is a version of the drug that was
previously approved. ANDAs applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products with
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness, or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved, (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved, and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for safety or
effectiveness reasons, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
FDA has become aware that the drug
products listed in the table are no longer
being marketed. (As requested by the
applicant, FDA withdrew approval of
NDA 050448 for GRIFULVIN
(griseofulvin) Oral Suspension in the
Federal Register of August 16, 2001 (66
FR 43017)).
Application No.
Drug
Applicant
NDA 011210 ......
NDA 012093 ......
TESSALON (benzonatate) Capsule; Oral 200 milligrams (mg)
ISORDIL (isosorbide dinitrate) Tablet; Oral 10 mg, 20 mg, 30
mg.
ACLOVATE (alclometasone dipropionate) Ointment; Topical
0.05%.
ACLOVATE (alclometasone dipropionate) Cream; Topical
0.05%.
SARAFEM (fluoxetine hydrochloride (HCl)) Capsule; Oral
Equivalent to (EQ) 10 mg Base, EQ 20 mg Base.
VASOCIDIN (prednisolone sodium phosphate; sulfacetamide
sodium), Solution/Drops; Ophthalmic, EQ 0.23% phosphate; 10%.
PRAVACHOL (pravastatin sodium) Tablet; Oral 10 mg ..........
Pfizer Inc., 1 Giralda Farms, Madison, NJ 07940.
Valeant Pharmaceuticals North America, LLC, 400 Somerset
Corporate Blvd., Bridgewater, NJ 08807.
Fougera Pharmaceuticals Inc., 60 Baylis Rd., P.O. Box 2006,
Melville, NY 11747.
Do.
NDA 018702 ......
NDA 018707 ......
NDA 018936 ......
NDA 018988 ......
NDA 019898 ......
NDA 020092 ......
NDA 021551 ......
NDA 021871 ......
mstockstill on DSK4VPTVN1PROD with NOTICES
NDA 050448 ......
NDA 050719 ......
ANDA 040454 ....
ANDA 062483 ....
VerDate Sep<11>2014
DILACOR XR (diltiazem HCl) Capsule, Extended-Release;
Oral 120 mg, 180 mg, 240 mg.
HALFLYTELY (polyethylene glycol 3350; potassium chloride;
sodium bicarbonate; sodium chloride) For Solution and
bisacodyl Delayed-Release Tablets); Oral 210 grams (g);
0.74 g; 2.86 g; 5.6 g; 5 mg.
LOESTRIN 24 FE (ethinyl estradiol; norethindrone acetate)
Tablet; Oral 0.02 mg; 1 mg.
GRIFULVIN V (griseofulvin, microcrystalline) Suspension;
Oral 125 mg/5 milliliters (mL).
HELIDAC (bismuth subsalicylate; metronidazole; tetracycline
HCl) Tablet, Chewable, Tablet, Capsule; Oral 262.4 mg;
250 mg, 500 mg.
PROMETHAZINE HYDROCHLORIDE (promethazine HCl)
Injectable; Injection 25 mg/mL, 50 mg/mL.
GRIFULVIN V (griseofulvin, microsize) Suspension; Oral 125
mg/5 mL.
16:30 Jul 17, 2015
Jkt 235001
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Eli Lilly and Co., Lilly Corp. Ctr., Indianapolis, IN 46285.
Novartis Pharmaceuticals Corp., 105 Eisenhower Pky., 280
Corporate Center, Roseland, NJ 07068.
Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ
08543–4000.
Actavis Laboratories UT, Inc., 577 Chipeta Way, Salt Lake
City, UT 84108.
Braintree Laboratories, Inc., 60 Columbia St., P.O. Box
850929, Braintree, MA 02185.
Warner Chilcott Co. LLC, Union Street Rd. 195 KM 1.1.,
Fajardo, Puerto Rico 00738.
Johnson & Johnson Consumer Products Co., 199 Grandview
Rd., Skillman, NJ 08558.
Prometheus Laboratories Inc., 9410 Carroll Park Dr., San
Diego, CA 92121.
Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA
19044.
Valeant Pharmaceuticals Luxembourg S.a.r.l, C/O Valeant
Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
E:\FR\FM\20JYN1.SGM
20JYN1
Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices
42829
Application No.
Drug
Applicant
ANDA 088762 ....
PROMETH W/DEXTROMETHORPHAN (dextromethorphan
hydrobromide; promethazine HCl) Syrup; Oral 15 mg/5 mL;
6.25 mg/5 mL.
G&W Laboratories Inc.,111 Coolidge St., South Plainfield, NJ
07080.
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. Accordingly, the Agency
will continue to list the drug products
listed in this document in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
NDAs and ANDAs listed in this
document are unaffected by the
discontinued marketing of the products
subject to those NDAs and ANDAs.
Additional ANDAs that refer to these
products may also be approved by the
Agency if they comply with relevant
legal and regulatory requirements. If
FDA determines that labeling for these
drug products should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–17730 Filed 7–17–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Bioequivalence Recommendations for
Lubiprostone; Revised Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a revised draft guidance
for industry on lubiprostone capsules
entitled ‘‘Bioequivalence
Recommendations for Lubiprostone.’’
The recommendations provide specific
guidance on the design of
bioequivalence (BE) studies to support
abbreviated new drug applications
(ANDAs) for lubiprostone capsules.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:30 Jul 17, 2015
Jkt 235001
DATES:
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 18,
2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Xiaoqiu Tang, Center for Drug
Evaluation and Research (HFD–600),
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm.
4730, Silver Spring, MD 20993–0002,
301–796–5850.
SUPPLEMENTARY INFORMATION:
capsules in January 2006. There are no
approved ANDAs for this product. In
August 2010, we issued a draft guidance
for industry on BE recommendations for
generic lubiprostone capsules. We are
now issuing a revised draft guidance for
industry on BE recommendations for
generic lubiprostone capsules
(‘‘Bioequivalence Recommendations for
Lubiprostone’’).
In January 2014, Sucampo Pharma
Americas, LLC, manufacturer of the
reference listed drug, AMITIZA,
submitted a citizen petition requesting
that FDA revise the BE requirements for
any new drug product that references
AMITIZA and seeks approval by means
of demonstrating BE to AMITIZA. FDA
has reviewed the issues raised in the
petition and is responding to the
petition (Docket No. FDA–2014–P–
0144).
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the design of BE studies to support
ANDAs for lubiprostone capsules. It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry,
‘‘Bioequivalence Recommendations for
Specific Products,’’ which explained the
process that would be used to make
product-specific BE recommendations
available to the public on FDA’s Web
site at https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm. As
described in that guidance, FDA
adopted this process as a means to
develop and disseminate productspecific BE recommendations and
provide a meaningful opportunity for
the public to consider and comment on
those recommendations. This notice
announces the availability of draft BE
recommendations for lubiprostone
capsules.
FDA initially approved new drug
application (NDA) 021908 for AMITIZA
II. Comments
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
E:\FR\FM\20JYN1.SGM
20JYN1
]]>Agencies
[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Pages 42828-42829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17730]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-2412]
Determination That TESSALON (Benzonatate) Capsules and Other Drug
Products Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined that the
drug products listed in this document were not withdrawn from sale for
reasons of safety or effectiveness. This determination means that FDA
will not begin procedures to withdraw approval of abbreviated new drug
applications (ANDAs) that refer to these drug products, and it will
allow FDA to continue to approve ANDAs that refer to the products as
long as they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
sponsors must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDAs applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products with Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness, or if FDA determines that the
listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162).
Under Sec. 314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
FDA has become aware that the drug products listed in the table are
no longer being marketed. (As requested by the applicant, FDA withdrew
approval of NDA 050448 for GRIFULVIN (griseofulvin) Oral Suspension in
the Federal Register of August 16, 2001 (66 FR 43017)).
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 011210............. TESSALON (benzonatate) Pfizer Inc., 1 Giralda
Capsule; Oral 200 Farms, Madison, NJ
milligrams (mg). 07940.
NDA 012093............. ISORDIL (isosorbide Valeant
dinitrate) Tablet; Pharmaceuticals North
Oral 10 mg, 20 mg, 30 America, LLC, 400
mg. Somerset Corporate
Blvd., Bridgewater,
NJ 08807.
NDA 018702............. ACLOVATE (alclometasone Fougera
dipropionate) Pharmaceuticals Inc.,
Ointment; Topical 60 Baylis Rd., P.O.
0.05%. Box 2006, Melville,
NY 11747.
NDA 018707............. ACLOVATE (alclometasone Do.
dipropionate) Cream;
Topical 0.05%.
NDA 018936............. SARAFEM (fluoxetine Eli Lilly and Co.,
hydrochloride (HCl)) Lilly Corp. Ctr.,
Capsule; Oral Indianapolis, IN
Equivalent to (EQ) 10 46285.
mg Base, EQ 20 mg Base.
NDA 018988............. VASOCIDIN (prednisolone Novartis
sodium phosphate; Pharmaceuticals
sulfacetamide sodium), Corp., 105 Eisenhower
Solution/Drops; Pky., 280 Corporate
Ophthalmic, EQ 0.23% Center, Roseland, NJ
phosphate; 10%. 07068.
NDA 019898............. PRAVACHOL (pravastatin Bristol-Myers Squibb
sodium) Tablet; Oral Co., P.O. Box 4000,
10 mg. Princeton, NJ 08543-
4000.
NDA 020092............. DILACOR XR (diltiazem Actavis Laboratories
HCl) Capsule, Extended- UT, Inc., 577 Chipeta
Release; Oral 120 mg, Way, Salt Lake City,
180 mg, 240 mg. UT 84108.
NDA 021551............. HALFLYTELY Braintree
(polyethylene glycol Laboratories, Inc.,
3350; potassium 60 Columbia St., P.O.
chloride; sodium Box 850929,
bicarbonate; sodium Braintree, MA 02185.
chloride) For Solution
and bisacodyl Delayed-
Release Tablets); Oral
210 grams (g); 0.74 g;
2.86 g; 5.6 g; 5 mg.
NDA 021871............. LOESTRIN 24 FE (ethinyl Warner Chilcott Co.
estradiol; LLC, Union Street Rd.
norethindrone acetate) 195 KM 1.1., Fajardo,
Tablet; Oral 0.02 mg; Puerto Rico 00738.
1 mg.
NDA 050448............. GRIFULVIN V Johnson & Johnson
(griseofulvin, Consumer Products
microcrystalline) Co., 199 Grandview
Suspension; Oral 125 Rd., Skillman, NJ
mg/5 milliliters (mL). 08558.
NDA 050719............. HELIDAC (bismuth Prometheus
subsalicylate; Laboratories Inc.,
metronidazole; 9410 Carroll Park
tetracycline HCl) Dr., San Diego, CA
Tablet, Chewable, 92121.
Tablet, Capsule; Oral
262.4 mg; 250 mg, 500
mg.
ANDA 040454............ PROMETHAZINE Teva Pharmaceuticals
HYDROCHLORIDE USA, 425 Privet Rd.,
(promethazine HCl) Horsham, PA 19044.
Injectable; Injection
25 mg/mL, 50 mg/mL.
ANDA 062483............ GRIFULVIN V Valeant
(griseofulvin, Pharmaceuticals
microsize) Suspension; Luxembourg S.a.r.l, C/
Oral 125 mg/5 mL. O Valeant
Pharmaceuticals North
America LLC, 400
Somerset Corporate
Blvd., Bridgewater,
NJ 08807.
[[Page 42829]]
ANDA 088762............ PROMETH W/ G&W Laboratories
DEXTROMETHORPHAN Inc.,111 Coolidge
(dextromethorphan St., South
hydrobromide; Plainfield, NJ 07080.
promethazine HCl)
Syrup; Oral 15 mg/5
mL; 6.25 mg/5 mL.
------------------------------------------------------------------------
FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
Approved ANDAs that refer to the NDAs and ANDAs listed in this
document are unaffected by the discontinued marketing of the products
subject to those NDAs and ANDAs. Additional ANDAs that refer to these
products may also be approved by the Agency if they comply with
relevant legal and regulatory requirements. If FDA determines that
labeling for these drug products should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.
Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17730 Filed 7-17-15; 8:45 am]
BILLING CODE 4164-01-P
