[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Notices]
[Pages 10535-10536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4037]



[[Page 10535]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]


Final Guidances for Industry Describing Product-Specific 
Bioequivalence Recommendations; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of final 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 (75 FR 
33311), FDA announced the availability of a guidance for industry, 
``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.

DATES: Submit written or electronic comments on Agency guidances at any 
time.

ADDRESSES: 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 recommendations.
    Submit electronic comments to http://www.regulations.gov. Submit 
written comments on product-specific BE recommendations to the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: 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:

I. Background

    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 at http://www.fda.gov/CDER/GUIDANCE/bioequivalence/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, 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. Once finalized, the 
recommendations are posted on FDA's Web site and announced in the 
Federal Register. This notice announces final product-specific 
recommendations that were posted on FDA's Web site in October 2011.
    For a complete history of previous 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 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.

II. Drug Products for Which Final Product-Specific BE Recommendations 
are Available

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

A

Acetaminophen; Caffeine; Dihydrocodeine Bitartrate

C

Cephalexin
Ciprofloxacin

D

Desmopressin Acetate

E

Eletriptan HBr

F

Fenoprofen Calcium
Fludrocortisone Acetate

G

Glimepiride; Pioglitazone

H

Hydroxyzine Pamoate (multiple RLDs)

I

Imatinib Mesylate

L

Lansoprazole
Levetiracetam
Linezolid

M

Meprobamate
Methotrexate Sodium (multiple RLDs)
Methylprednisolone Acetate
Metoclopramide HCl

N

Nadolol
Nifedipine
Nilutamide
Nisoldipine
Nitazoxanide
Nitrofurantoin
Nitrofurantoin Macrocrystalline

O

Oxybutynin Chloride

P

Phendimetrazine Tartrate (multiple RLDs)
Phentermine HCl (multiple RLDs)
Phytonadione
Pregabalin
Propafenone HCl
Pyridostigmine Bromide

R

Raltegravir Potassium
Ramelteon

S

Scopolamine
Selegiline
Sorafenib Tosylate

T

Tamoxifen Citrate
Telbivudine
Temazepam
Terbinafine HCl
Toremifene Citrate

V

Voriconazole

Z

Zolpidem

III. Comments

    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. Identify comments with the 
docket number found in brackets in the heading of this document. The

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guidance, notices, and received comments are available for public 
examination in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.
    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 
through FDMS only at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/CDER/GUIDANCE/bioequivalence/default.htm or 
http://www.regulations.gov.

    Dated: February 14, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4037 Filed 2-21-12; 8:45 am]
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