Determination That ATROVENT (Ipatropium Bromide) Inhalation Solution and 10 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 57109-57111 [E8-23035]
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57109
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices
following: (1) Whether to grant HUD
designation of a medical device; (2)
exempt a HUD from the effectiveness
requirements under sections 514 and
515 of the act, provided that the device
meets requirements set forth under
section 520(m) of the act; and (3)
whether to grant marketing approval(s)
for the HUD. Failure to collect this
information would prevent FDA from
or condition; and (3) will not expose
patients to an unreasonable or
significant risk of illness or injury with
the probable benefit to health from
using the device outweighing the risk of
injury or illness from its use. This takes
into account the probable risks and
benefits of currently available devices or
alternative forms of treatment.
The information collected will assist
FDA in making determinations on the
making a determination on the factors
listed previously in this document.
Further, the collected information
would also enable FDA to determine
whether the holder of a HUD is in
compliance with the HUD provisions
under section 520(m) of the act.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
Annual Frequency per
Response
No. of Respondents
Total Annual Responses
Hours per Response
Total Hours
814.102
14
1
14
40
560
814.104
6
1
6
320
1,920
814.106
6
2
12
50
600
814.108
32
1
32
80
2,560
814.116(e)(3)
1
1
1
1
1
814.124(a)
5
1
5
1
5
814.24(b)
4
1
4
2
8
45
1
45
120
5,400
814.126(b)(1)
Total
1 There
11,054
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of Recordkeepers
Annual Frequency per
Recordkeeping
Total Annual Records
45
21 CFR Section
1
45
814.126(b)(2)
Hours per Record
2
Total
jlentini on PROD1PC65 with NOTICES
1 There
Total Hours
90
90
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents in Tables
1 and 2 of this document are an average
from data for the previous 3 years, i.e.,
FY 2005–2007. The number of annual
reports submitted under § 814.126(b)(1)
in Table 1 reflects an increase to 45
respondents with approved HUD
applications. Likewise, under
§ 814.126(b)(2) in Table 2, the number of
recordkeepers increased to 45.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: September 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–22991 Filed 9–30–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0506]
Determination That ATROVENT
(Ipatropium Bromide) Inhalation
Solution and 10 Other Drug Products
Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Aug<31>2005
18:22 Sep 30, 2008
Jkt 214001
PO 00000
Notice.
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Fmt 4703
Sfmt 4703
SUMMARY: The Food and Drug
Administration (FDA) has determined
that the 11 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:
Olivia Pritzlaff, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6308,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
E:\FR\FM\01OCN1.SGM
01OCN1
57110
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices
Food, Drug, and Cosmetic Act (the 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 withdrawn 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 reasons of
safety or effectiveness, 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 in this
document are no longer being marketed.
(As requested by the applicant, FDA
withdrew approval of NDA 20–228 for
ATROVENT (ipratropium bromide)
Inhalation Solution in the Federal
Register of November 7, 2007 (72 FR
62858).)
Drug
Restoration Act of 1984 (Public Law 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. Sponsors of
ANDAs do not have to repeat the
extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Applicant
Application No.
ATROVENT (ipratropium bromide) Inhalation
Solution, 0.02%
Boehringer Ingelheim Pharmaceuticals, Inc.,
900 Ridgebury Rd., P.O. Box 368,
Ridgefield, CT 06877–0368
NDA 20–306
Fludeoxyglucose F–18 (4–40 millicuries
(mCi)/milliliter (mL) and 4–90 mCi/mL) Injection
Downstate Clinical PET Center, Methodist
Medical Center, 112 Crescent Ave., Peoria,
IL 61606
NDA 20–333
AGRYLIN (anagrelide hydrochloride (HCl))
Capsules, equivalent to (EQ) 1 milligram
(mg) base
Shire US Inc., 725 Chesterbrook Blvd.,
Wayne, PA 19087–5637
NDA 20–377
CORDARONE (amiodarone HCl) Injection, 50
mg/mL
Wyeth Pharmaceuticals, P.O. Box 8299,
Philadelphia, PA 19101–8299
NDA 20–974
PROZAC (fluoxetine HCl) Tablets, EQ 10 mg
base
Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285
NDA 50–417
NEOSPORIN (bacitracin zinc; neomycin sulfate; polymyxin B sulfate) Ophthalmic Ointment, 400 units/gram (g); EQ 3.5 mg base/
g; 10,000 units/g
Monarch Pharmaceuticals, Inc., c/o King
Pharmaceuticals, Inc., 501 Fifth St., Bristol,
TN 37620
NDA 50–461
ANCEF (cefazolin sodium) Injection, 250 mg/
vial, 500 mg/vial, and 5 g/vial
GlaxoSmithKline, 2301 Renaissance Blvd.,
King of Prussia, PA 19406
NDA 50–521
CECLOR (cefaclor) Capsules, EQ 250 mg
and 500 mg base
Eli Lilly and Co.
NDA 50–522
CECLOR (cefaclor) Oral Suspension, EQ 125
mg base/5 mL and EQ 250 mg base/5 mL
Do.
NDA 50–527
DURICEF (cefadroxil) Oral Suspension, EQ
125 mg base/5 mL
Warner Chilcott, Inc., Rockaway 80 Corporate Center, 100 Enterprise Dr., suite
280, Rockaway, NJ 07866
ANDA 61–229
jlentini on PROD1PC65 with NOTICES
NDA 20–228
POLYSPORIN (bacitracin zinc; polymyxin B
sulfate) Ophthalmic Ointment, 500 units/g;
10,000 units/g
Monarch Pharmaceuticals, Inc.
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
VerDate Aug<31>2005
18:22 Sep 30, 2008
Jkt 214001
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
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products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
NDAs listed in this document are
unaffected by the discontinued
E:\FR\FM\01OCN1.SGM
01OCN1
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices
marketing of the products subject to
those NDAs. 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: September 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–23035 Filed 9–30–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0484]
Preparation for International
Conference on Harmonization
Meetings in Brussels, Belgium; Public
Meeting; Correction
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice of meeting; correction.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
correction to the notice of a public
meeting entitled ‘‘Preparation for
International Conference on
Harmonization Meetings in Brussels,
Belgium; Public Meeting.’’ This meeting
was announced in the Federal Register
of September 16, 2008 (73 FR 53428).
The correction is being made to reflect
changes in the Summary, Date and
Time, Location, Contact Person,
Background, and Agenda portions of the
document.
FOR FURTHER INFORMATION CONTACT:
Tammie Jo Bell, Office of the
Commissioner, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, by email:
Tammie.Bell2@fda.hhs.gov or fax: 301–
827–0003.
SUPPLEMENTARY INFORMATION: The FDA
is correcting a notice published in the
Federal Register of September 16, 2008
(73 FR 53428), announcing a meeting
entitled ‘‘Preparation for International
Conference on Harmonization Meetings
in Brussels, Belgium.’’ This corrected
notice is being published in its entirety:
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting entitled ‘‘Preparation for
International Conference on
Harmonization Meetings in Brussels,
Belgium’’ to provide information and
VerDate Aug<31>2005
18:22 Sep 30, 2008
Jkt 214001
receive comments on the International
Conference on Harmonization (ICH) as
well as the upcoming meetings in
Brussels, Belgium. The topics to be
discussed are the topics for discussion
at the forthcoming ICH Steering
Committee Meeting. The purpose of the
meeting is to solicit public input prior
to the next Steering Committee and
Expert Working Groups meetings in
Brussels, Belgium, November 10 to 13,
2008, at which discussion of the topics
underway and the future of ICH will
continue, as well as provide
comprehensive updates of the various
ICH topics.
Date and Time: The meeting will be
held on Tuesday, October 21, 2008,
from 2:30 p.m. to 5:30 p.m.
Location: The meeting will be held at
5600 Fishers Lane, 3rd floor, Conference
Rooms D and E, Rockville, MD 20857.
For security reasons, all attendees are
asked to arrive no later than 2:15 p.m.,
as you will be escorted from the front
entrance of 5600 Fishers Lane to
Conference Rooms D and E.
Contact Person: All participants must
register with Tammie Jo Bell, Office of
the Commissioner, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, by email:
Tammie.Bell2@fda.hhs.gov or fax: 301–
827–0003.
Registration and Requests for Oral
Presentations: Send registration
information (including name, title, firm
name, address, telephone, and fax
number), written material, and requests
to make oral presentation, to the contact
person by October 14, 2008.
If you need special accommodations
due to a disability, please contact
Tammie Jo Bell at least 7 days in
advance.
Transcripts: Transcripts of the
meeting may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
12A–66, Rockville, MD 20857,
approximately 15 working days after the
meeting at a cost of 10 cents per page.
Background: The ICH was established
in 1990 as a joint regulatory/industry
project to improve, through
harmonization, the efficiency of the
process for developing and registering
new medicinal products in Europe,
Japan, and the United States without
compromising the regulatory obligations
of safety and effectiveness.
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
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57111
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for medical product
development among regulatory
agencies. ICH was organized to provide
an opportunity for harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. ICH is concerned with
harmonization among three regions: The
European Union, Japan, and the United
States. The six ICH sponsors are the
European Commission; the European
Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of
Health, Labor and Welfare; the Japanese
Pharmaceutical Manufactures
Association; the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and Health Canada, the
European Free Trade Area and the
World Health Organization. The ICH
process has achieved significant
harmonization of the technical
requirements for the approval of
pharmaceuticals for human use in the
three ICH regions.
The current ICH process and structure
can be found at the following Web site:
https://www.ich.org.
Interested persons may present data,
information, or views orally or in
writing, on issues pending at the public
meeting. Time allotted for oral
presentations may be limited to 10
minutes. Those desiring to make oral
presentations should notify the contact
person by October 14, 2008, and submit
a brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses,
phone number, fax, and email of
proposed participants, and an
indication of the approximate time
requested to make their presentation.
Agenda: The agenda for the public
meeting will be made available via the
internet at https://www.fda.gov/cder/
meeting/ICH_20081021.htm.
E:\FR\FM\01OCN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 191 (Wednesday, October 1, 2008)]
[Notices]
[Pages 57109-57111]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23035]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0506]
Determination That ATROVENT (Ipatropium Bromide) Inhalation
Solution and 10 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
11 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: Olivia Pritzlaff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6308, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term
[[Page 57110]]
Restoration Act of 1984 (Public Law 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. Sponsors of ANDAs do not have to repeat the
extensive clinical testing otherwise necessary to gain approval of a
new drug application (NDA). The only clinical data required in an ANDA
are data to show that the drug that is the subject of the ANDA is
bioequivalent to the listed drug.
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (the 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 withdrawn 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 Sec. 10.25(a) and Sec. 10.30. Section 314.161(d)
provides that if FDA determines that a listed drug was withdrawn from
sale for reasons of safety or effectiveness, 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 in
this document are no longer being marketed. (As requested by the
applicant, FDA withdrew approval of NDA 20-228 for ATROVENT
(ipratropium bromide) Inhalation Solution in the Federal Register of
November 7, 2007 (72 FR 62858).)
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 20-228 ATROVENT (ipratropium Boehringer Ingelheim
bromide) Inhalation Pharmaceuticals,
Solution, 0.02% Inc., 900 Ridgebury
Rd., P.O. Box 368,
Ridgefield, CT 06877-
0368
------------------------------------------------------------------------
NDA 20-306 Fludeoxyglucose F-18 (4- Downstate Clinical PET
40 millicuries (mCi)/ Center, Methodist
milliliter (mL) and 4- Medical Center, 112
90 mCi/mL) Injection Crescent Ave.,
Peoria, IL 61606
------------------------------------------------------------------------
NDA 20-333 AGRYLIN (anagrelide Shire US Inc., 725
hydrochloride (HCl)) Chesterbrook Blvd.,
Capsules, equivalent Wayne, PA 19087-5637
to (EQ) 1 milligram
(mg) base
------------------------------------------------------------------------
NDA 20-377 CORDARONE (amiodarone Wyeth Pharmaceuticals,
HCl) Injection, 50 mg/ P.O. Box 8299,
mL Philadelphia, PA
19101-8299
------------------------------------------------------------------------
NDA 20-974 PROZAC (fluoxetine HCl) Eli Lilly and Co.,
Tablets, EQ 10 mg base Lilly Corporate
Center, Indianapolis,
IN 46285
------------------------------------------------------------------------
NDA 50-417 NEOSPORIN (bacitracin Monarch
zinc; neomycin Pharmaceuticals,
sulfate; polymyxin B Inc., c/o King
sulfate) Ophthalmic Pharmaceuticals,
Ointment, 400 units/ Inc., 501 Fifth St.,
gram (g); EQ 3.5 mg Bristol, TN 37620
base/g; 10,000 units/g
------------------------------------------------------------------------
NDA 50-461 ANCEF (cefazolin GlaxoSmithKline, 2301
sodium) Injection, 250 Renaissance Blvd.,
mg/vial, 500 mg/vial, King of Prussia, PA
and 5 g/vial 19406
------------------------------------------------------------------------
NDA 50-521 CECLOR (cefaclor) Eli Lilly and Co.
Capsules, EQ 250 mg
and 500 mg base
------------------------------------------------------------------------
NDA 50-522 CECLOR (cefaclor) Oral Do.
Suspension, EQ 125 mg
base/5 mL and EQ 250
mg base/5 mL
------------------------------------------------------------------------
NDA 50-527 DURICEF (cefadroxil) Warner Chilcott, Inc.,
Oral Suspension, EQ Rockaway 80 Corporate
125 mg base/5 mL Center, 100
Enterprise Dr., suite
280, Rockaway, NJ
07866
------------------------------------------------------------------------
ANDA 61-229 POLYSPORIN (bacitracin Monarch
zinc; polymyxin B Pharmaceuticals, Inc.
sulfate) Ophthalmic
Ointment, 500 units/g;
10,000 units/g
------------------------------------------------------------------------
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 listed in this document are
unaffected by the discontinued
[[Page 57111]]
marketing of the products subject to those NDAs. 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: September 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-23035 Filed 9-30-08; 8:45 am]
BILLING CODE 4160-01-S
