Food and Drug Administration, HHS.
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 The guidances are being withdrawn because they are outdated and of little use to the generic drug industry.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.
General comments on agency guidance documents are welcome at any time.
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.Start Further Info
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.End Further Info End Preamble Start Supplemental 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 The guidances are being withdrawn because they are outdated and of limited use to the generic drug industry.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development of generic drug products with the goal of identifying documents that need to be revised, reformatted, or withdrawn because they are no longer current (64 FR 36886, July 8, 1999).
The following guidances are withdrawn:
|Guidance||Date of Issuance|
|Acetaminophen, Aspirin and Codeine Phosphate Tablets and Acetaminophen, Aspirin and Codeine Phosphate Capsules||Revised December 1993|
|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, Acetaminophen and Caffeine Capsules USP||September 1997|
|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|
|Start Printed 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 Ointment USP||Revised April 1992|
|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 Ophthalmic Ointment USP||Revised August 1993|
|Sulfacetamide Sodium and Prednisolone Acetate||Revised January 1995|
|Sulfamethoxazole and Trimethoprim Tablets USP and Sulfamethoxazole and Trimethoprim Oral Suspension USP||Revised August 1993|
|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|
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.Start Signature
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