[Federal Register Volume 79, Number 183 (Monday, September 22, 2014)]
[Notices]
[Pages 56588-56589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22450]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Bioequivalence Recommendations for Estradiol Vaginal Cream; Draft 
Guidance for Industry; Availability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availability of a revised draft guidance for industry entitled ``Draft 
Guidance on Estradiol.'' The guidance provides specific recommendations 
on the design of bioequivalence (BE) studies to support abbreviated new 
drug applications (ANDAs) for estradiol vaginal cream. This draft 
guidance is a revised version of a previously issued draft guidance of 
the same subject.

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 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 21, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993. 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electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Kris Andr[eacute], Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1615, Silver Spring, MD 20993, 240-402-
7800.

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 to provide a meaningful opportunity for the public to consider and 
comment on those recommendations. This notice announces the 
availability of revised draft BE recommendations for estradiol vaginal 
cream.
    ANDA 086069 for Estrace Cream (estradiol vaginal cream, USP, 0.01%) 
was initially approved by FDA in January 1984. In August 2009, FDA 
issued a draft guidance for industry on BE recommendations for generic 
estradiol vaginal cream. FDA is now issuing a revised version of the 
draft BE recommendations for estradiol vaginal cream. This revised 
draft guidance changes the recommendation for an in

[[Page 56589]]

vivo pharmacokinetic BE study from a parallel study design to a 
crossover study design, but is the same in all other respects.
    In January 2005, Warner Chilcott, Inc., submitted a citizen 
petition requesting that FDA stay final approval and/or the effective 
date of final approval of any ANDA that relies on Estrace Cream as the 
reference listed drug unless the ANDA meets certain requirements 
related to demonstrating bioequivalence. FDA reviewed the issues raised 
in the petition and is responding to the petition (see FDA letter to 
Warner Chilcott, Inc, Docket No. FDA-2005-P-0006, available at http://www.regulations.gov).
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on the design 
of BE studies to support ANDAs for estradiol vaginal cream. It does not 
create or confer any rights for or on any person and does 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. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. 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 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22450 Filed 9-19-14; 8:45 am]
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