[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Notices]
[Page 58399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23177]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Bioequivalence Recommendations for 
Pentosan Polysulfate Sodium Capsule; 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availability of a draft guidance for industry entitled ``Bioequivalence 
Recommendations for Pentosan Polysulfate Sodium.'' The recommendations 
provide specific guidance on the design of bioequivalence (BE) studies 
to support abbreviated new drug applications (ANDAs) for pentosan 
polysulfate sodium capsule.

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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 19, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: 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-2007-D-
0433), FDA announced the availability of a guidance for industry 
entitled ``Bioequivalence Recommendations for Specific Products'' that 
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. This notice announces the 
availability of draft BE recommendations for pentosan polysulfate 
sodium capsule.
    New drug application 020193 for Elmiron (pentosan polysulfate 
sodium) capsule was initially approved by FDA in September 1996. There 
are no approved ANDAs for this product. FDA is now issuing a draft 
guidance for industry on BE recommendations for generic pentosan 
polysulfate sodium capsule (Draft Pentosan Polysulfate Sodium Capsule 
BE Recommendations).
    In March 2012, Janssen Pharmaceuticals, Inc. (Janssen), 
manufacturer of the reference listed drug (RLD), Elmiron, submitted 
(through its attorneys) a citizen petition requesting that FDA require 
that any ANDA referencing Elmiron meet certain conditions, including 
conditions related to demonstrating BE (Docket No. FDA-2012-P-0295). 
FDA is reviewing the issues raised in the petition. FDA will consider 
any comments on the Draft Pentosan Polysulfate Sodium Capsule BE 
Recommendations before responding to Janssen's citizen petition.
    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 pentosan polysulfate sodium capsule. 
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 written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. 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 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23177 Filed 9-19-12; 8:45 am]
BILLING CODE 4160-01-P