[Federal Register Volume 67, Number 129 (Friday, July 5, 2002)]
[Notices]
[Pages 44857-44858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-16796]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02N-0253]
Withdrawal of 53 Guidances on Individual Product Labeling
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of 53 individual product labeling guidances. The guidances
are being withdrawn because they are outdated and of little use to the
generic drug industry. The agency has developed other guidance and
resources to assist industry in obtaining up-to-date labeling for
reference listed drugs.
DATES: General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Submit written requests for the guidance for
industry entitled ``Revising ANDA Labeling Following Revision of the
RLD Labeling'' to the Division of Drug Information (HFD-240), Center
for Drug Evaluation and Research, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857. See the SUPPLEMENTARY INFORMATION
section for electronic access to agency guidance documents.
FOR FURTHER INFORMATION CONTACT: Rita Hassall, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-5845.
SUPPLEMENTARY INFORMATION: FDA is announcing the withdrawal of 53
individual product labeling guidances. These labeling guidances,
currently available on the Center for Drug Evaluation and Research
(CDER) guidance list, were intended to provide sponsors of abbreviated
new drug applications (ANDAs) with product specific templates for
package insert labeling that would be accepted by the Office of Generic
Drugs (OGD). Package insert labeling for innovator products changes
frequently, and it is difficult to keep the guidances updated. The
guidances are being withdrawn because they are outdated and of limited
use to the generic drug industry.
The withdrawal of these 53 product specific labeling guidances is
part of a long-term effort in OGD to review guidance documents on the
development of generic drug products with the goal of identifying
documents that need to be revised, reformatted, or withdrawn because
they are no longer current (64 FR 36886, July 8, 1999).
The following guidances are withdrawn:
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Guidance Date of Issuance
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Acetaminophen, Aspirin and Codeine Phosphate Tablets and Acetaminophen, Revised December 1993
Aspirin and Codeine Phosphate Capsules
Acetaminophen and Codeine Phosphate Oral Solution and Oral Suspension Revised December 1993
Alprazolam Tablets Revised August 1996
Amiloride Hydrochloride and Hydrochlorothiazide Tablets USP September 1997
Amlodipine Besylate Tablets September 1997
Astemizole Tablets September 1997
Atenolol Tablets August 1997
Butalbital, Acetaminophen and Caffeine Tablets USP or Butalbital, September 1997
Acetaminophen and Caffeine Capsules USP
Butalbital, Acetaminophen, Caffeine and Hydrocodone Bitartrate Tablets September 1997
Butorphanol Tartrate Injection USP Revised October 1992
Captopril and Hydrochlorothiazide Tablets USP April 1995
Captopril Tablets February 1995
Carbidopa and Levodopa Tablets USP Revised February 1992
Cimetidine Hydrochloride Injection September 1995
Cimetidine Tablets USP Revised September 1995
Cisapride Oral Suspension September 1997
Cisapride Tablets September 1997
Clindamycin Phosphate Injection, USP Revised September 1998
Diclofenac Sodium Delayed-Release Tablets Revised February 1995
Diltiazem Hydrochloride Extended-Release Capsules Revised September 1995
[[Page 44858]]
Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP April 1995
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP April 1995
Fludeoxyglucose F18 Injection January 1997
Flurbiprofen Tablets USP Revised January 1994
Fluvoxamine Maleate Tablets September 1997
Gentamicin Sulfate Ophthalmic Solution USP and Gentamicin Sulfate Ophthalmic Revised April 1992
Ointment USP
Heparin Sodium Injection USP Revised March 1991
Hydrocodone Bitartrate and Acetaminophen Tablets USP Revised April 1994
Indomethacin Capsules USP Revised September 1995
Itraconazole Capsules September 1998
Leucovorin Calcium for Injection July 1996
Leucovorin Calcium Tablets USP July 1996
Medroxyprogesterone Acetate Tablets USP Revised September 1998
Metaproternol Sulfate Inhalation Solution USP Revised May 1992
Metaproterenol Sulfate Syrup USP Revised May 1992
Metaproterenol Sulfate Tablets USP Revised May 1992
Metoclopramide Tablets USP and Metoclopramide Oral Solution USP Revised February 1995
Naproxen Sodium Tablets USP September 1997
Naproxen Tablets USP September 1997
Paclitaxel Injection September 1997
Quinidine Sulfate Tablets, USP October 1995
Ranitidine Tablets USP Revised November 1993
Risperidone Oral Solution September 1997
Risperidone Tablets September 1997
Sulfacetamide Sodium Ophthalmic Solution USP and Sulfacetamide Sodium Revised August 1993
Ophthalmic Ointment USP
Sulfacetamide Sodium and Prednisolone Acetate Revised January 1995
Sulfamethoxazole and Trimethoprim Tablets USP and Sulfamethoxazole and Revised August 1993
Trimethoprim Oral Suspension USP
Theophylline Revised February 1995
Theophylline Intravenous Dosage Forms September 1995
Tobramycin Sulfate Injection USP Revised May 1993
Venlafaxine Hydrochloride Tablets October 1997
Verapamil Hydrochloride Tablets October 1991
Zolpidem Tartrate Tablets September 1997
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In May 2000, the agency issued the guidance for industry entitled
``Revising ANDA Labeling Following Revision of the RLD Labeling.'' This
guidance provides information on how to access current package insert
labeling on OGD's Labeling Review Branch Web site at http://www.fda.gov/cder/ogd/rld/labeling_review_branch.htm.
Interested persons may submit written or electronic comments to the
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Two copies of any comments
are to be submitted, except that individuals may submit one copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments are available for
public examination in the Dockets Management Branch between 9 a.m. and
4 p.m., Monday through Friday.
Persons with access to the Internet may obtain CDER guidance
documents at http://www.fda.gov/cder/guidance/index.htm.
Dated: June 24, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-16796 Filed 7-3-02; 8:45 am]
BILLING CODE 4160-01-S