Skip to Content
Notice

Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability

Action

Notice.

Summary

The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled “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. The BE recommendations identified in this notice were developed using the process described in that guidance.

 

Table of Contents Back to Top

DATES: Back to Top

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 these draft and revised draft guidances before it begins work on the final versions of the guidances, submit either electronic or written comments on the draft and revised draft product-specific BE recommendations listed in this notice by May 21, 2012.

ADDRESSES: Back to Top

Submit written requests for single copies of the individual BE guidances to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, 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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance recommendations.

Submit electronic comments on the draft product-specific BE recommendations to http://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: Back to Top

Doan T. Nguyen, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, (240) 276-8608.

SUPPLEMENTARY INFORMATION: Back to Top

I. Background Back to Top

In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled “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 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. Under that process, draft recommendations are posted on FDA's Web site and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received and either publishes final recommendations, or publishes revised draft recommendations for comment. Recommendations were last announced in the Federal Register of January 25, 2012 (77 FR 3777). This notice announces draft product-specific recommendations, either new or revised, that are being posted on FDA's Web site concurrently with publication of this notice.

II. Drug Products for Which New Draft Product-Specific Back to Top

BE Recommendations Are Available

FDA is announcing new draft product-specific BE recommendations for drug products containing the following active ingredients:

A

Acyclovir (multiple reference listed drugs (RLDs),

Amiloride,

B

Butenafine HCl (multiple RLDs),Chlorpromazine HCl,

C

Clindamycin Phosphate (multiple RLDs),

D

Dalfampridine,

Dexmethylphenidate HCl,

Dextromethorphan HBr; Quinidine Sulfate,

Diclofenac Epolamine,

Drospirenone Ethinyl Estradiol; Levomefolate,

E

Ethinyl Estradiol; Norethindrone,

F

Fenofibrate,

Fludarabine,

Fulvestrant,

G

Glyburide (multiple RLDs),

Granisetron,

I

Ivermectin,

K

Ketoconazole (multiple RLDs),

M

Memantine HCl,

Metformin Hydrochloride; Saxagliptin,

N

Naftifine HCl (multiple RLDs),

Nitrofurantoin; Nitrofurantoin Macrocrystalline,

O

Ondansetron,

Oxiconazole Nitrate (multiple RLDs),

P

Pimecrolimus,

Procarbazine,

Propylthiouracil,

S

Sumatriptan,

T

Tacrolimus (multiple strengths),

Tolvaptan,

Tretinoin (multiple RLDs),

V

Vardenafil HCl,

III. Drug Products for Which Revised Draft Product-Specific BE Back to Top

Recommendations Are Available

FDA is announcing revised draft product-specific BE recommendations for drug products containing the following active ingredients:

B

Benzoyl Peroxide; Clindamycin Phosphate (multiple RLDs),

Bosentan,

C

Cholestyramine,

Colesevelam,

D

Dexamethasone; Tobramycin (multiple RLDs),

H

Hydrochlorothiazide; Irbesartan,

L

Loteprednol,

Loteprednol; Tobramycin,

P

Paliperidone

For a complete history of previously published Federal Register notices relating to product-specific BE recommendations, please go to http://www.regulations.gov and enter docket number FDA-2007-D-0369.

These draft and revised draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidances represent the Agency's current thinking on product-specific design of BE studies to support ANDAs. They do not create or confer any rights for or on any person and do 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.

IV. Comments Back to Top

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments on any of the specific BE recommendations posted on FDA's Web site. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. The guidance, notices, and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access Back to Top

Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

Dated: March 16, 2012.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2012-6947 Filed 3-21-12; 8:45 am]

BILLING CODE 4160-01-P

Site Feedback