[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]]

-----------------------------------------------------------------------

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Draft Guidance for Industry on Bioequivalence Recommendations for 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.

-----------------------------------------------------------------------

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availability of a revised draft guidance for industry entitled 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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 3, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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