[Federal Register Volume 78, Number 234 (Thursday, December 5, 2013)]
[Notices]
[Page 73200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-29080]
[[Page 73200]]
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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Draft Guidance for Industry on Bioequivalence Recommendations for
Paliperidone Palmitate Extended-Release Injectable Suspension;
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availability of a revised draft guidance for industry entitled
``Bioequivalence Recommendations for Paliperidone Palmitate.'' The
guidance provides specific recommendations on the design of
bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs) for paliperidone palmitate extended-release
injectable suspension.
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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 3, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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, 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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Kris Andre, 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. This notice announces the
availability of revised draft BE recommendations for paliperidone
palmitate extended-release injectable suspension.
New drug application 022264 for INVEGA SUSTENNA (paliperidone
palmitate) extended-release injectable suspension was initially
approved by FDA in July 2009. In August 2011, FDA issued a draft
guidance for industry on BE recommendations for generic paliperidone
palmitate (Draft BE Recommendations for Paliperidone Palmitate). FDA is
now issuing a revised version of the Draft BE Recommendations for
Paliperidone Palmitate Extended-Release Injectable Suspension (Revised
Draft BE Recommendations).
In May 2013, Janssen Research & Development, LLC, submitted a
citizen petition requesting that FDA require that any ANDA referencing
INVEGA SUSTENNA (paliperidone palmitate) extended-release injectable
suspension meet certain conditions, including conditions related to
demonstrating BE (Docket No. FDA-2013-P-0608). FDA is reviewing the
issues raised in the petition. FDA will consider any comments on the
Revised Draft BE Recommendations in responding to the 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 paliperidone palmitate extended-
release injectable suspension. 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: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-29080 Filed 12-4-13; 8:45 am]
BILLING CODE 4160-01-P