Federal Register, Volume 77 Issue 179 (Friday, September 14, 2012)

[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access to the draft guidance recommendations.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:

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

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

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

Dalteparin sodium

Estramustine phosphate sodium

Fentanyl citrate

Ketoconazole

Linagliptin

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

Nifedipine

Omega-3-acid ethyl esters
Omeprazole

Paclitaxel
Pazopanib hydrochloride
Progesterone

Rilpivirine hydrochloride
Roflumilast

Saxagliptin hydrochloride

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:

Azacitidine
Azelaic acid

Capecitabine

Estrogen, esterified
Etravirine

Hydrochlorothiazide; losartan potassium

Lopinavir; ritonavir

Phytonadione (multiple RLDs and dosage forms)
Propranolol hydrochloride

Sapropterin dihydrochloride
Sumatriptan

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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