[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]
-----------------------------------------------------------------------
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Draft Guidance for Industry on Bioequivalence Recommendations for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.
-----------------------------------------------------------------------
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availability of a draft guidance for industry entitled ``Bioequivalence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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 19, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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