[Federal Register Volume 77, Number 179 (Friday, September 14, 2012)]
[Notices]
[Pages 56851-56853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22658]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369 (formerly Docket 2007D-0168)]


Draft and Revised Draft 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 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

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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.

DATES: 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 November 13, 2012.

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access to the draft guidance recommendations.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: K. Geoffrey Wu, Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9326.

SUPPLEMENTARY INFORMATION:

I. Background

    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 June 14, 2012 (77 FR 35688). 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 BE 
Recommendations Are Available

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

A

Amoxicillin
Amoxicillin; clavulanate potassium
Amphetamine aspartate; amphetamine sulfate; dextroamphetamine 
saccharate; dextroamphetamine sulfate

B

Budesonide
Bupropion hydrochloride (multiple reference listed drugs (RLDs))

C

Calcitonin salmon
Carbidopa; levodopa
Carglumic acid
Ciclesonide
Ciprofloxacin; dexamethasone
Cyclophosphamide

D

Dalteparin sodium

E

Estramustine phosphate sodium

F

Fentanyl citrate

K

Ketoconazole

L

Linagliptin

M

Mesalamine (multiple RLDs and dosage forms)
Methylphenidate hydrochloride (multiple RLDs)

N

Nifedipine

O

Omega-3-acid ethyl esters
Omeprazole

P

Paclitaxel
Pazopanib hydrochloride
Progesterone

R

Rilpivirine hydrochloride
Roflumilast

S

Saxagliptin hydrochloride

T

Telaprevir
Tenofovir disoproxil fumarate
Thioguanine
Thalidomide
Tretinoin (multiple RLDs and dosage forms)

III. Drug Products for Which Revised Draft Product-Specific BE 
Recommendations Are Available

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

A

Azacitidine
Azelaic acid

C

Capecitabine

E

Estrogen, esterified
Etravirine

H

Hydrochlorothiazide; losartan potassium

L

Lopinavir; ritonavir

P

Phytonadione (multiple RLDs and dosage forms)
Propranolol hydrochloride

S

Sapropterin dihydrochloride
Sumatriptan

T

Tadalafil
Theophylline (multiple RLDs)
Tolterodine tartrate
Topiramate
Trazodone hydrochloride
    For a complete history of previously published Federal Register 
notices related 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). These 
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

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alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

IV. 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 
guidances, 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

    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: September 4, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-22658 Filed 9-13-12; 8:45 am]
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