[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are being withdrawn because they are outdated and of little use to the 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guidances are being withdrawn because they are outdated and of limited 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