80 FR 30255 - Bioequivalence Recommendations for Risperidone; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 101 (May 27, 2015)

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on risperidone injection entitled ``Draft Guidance on Risperidone.'' The recommendations provide specific guidance on the design of studies to support abbreviated new drug applications (ANDAs) for risperidone injection. This draft guidance is the second revision of a previously issued draft guidance on the same subject.

[Federal Register Volume 80, Number 101 (Wednesday, May 27, 2015)]
[Notices]
[Page 30255]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-12847]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Bioequivalence Recommendations for Risperidone; Draft Guidance 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availability of a draft guidance for industry on risperidone injection 
entitled ``Draft Guidance on Risperidone.'' The recommendations provide 
specific guidance on the design of studies to support abbreviated new 
drug applications (ANDAs) for risperidone injection. This draft 
guidance is the second revision of a previously issued draft guidance 
on 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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 27, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 
20993-0002. 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section for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Xiaoqiu Tang, Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 
301-796-5850.

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA 
announced the availability of a guidance for industry, ``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 bioequivalence (BE) 
recommendations and provide a meaningful opportunity for the public to 
consider and comment on those recommendations. This notice announces 
the availability of a second revision of draft BE recommendations for 
risperidone injection.
    FDA initially approved new drug application 021346 for Risperdal 
Consta Long-Acting Injection in October 2003. There are no approved 
ANDAs for this product. In February 2010, FDA issued a draft guidance 
for industry on BE recommendations for generic risperidone injection. 
In August 2013, we issued a revised draft guidance on the same subject. 
We are now issuing a second revision of the draft guidance for industry 
on BE recommendations for generic risperidone injection (Draft Guidance 
on Risperidone).
    In February 2011, Johnson & Johnson Pharmaceutical Research and 
Development, LLC, manufacturer of Risperdal Consta, the reference 
listed drug, submitted a citizen petition requesting that FDA require 
that any ANDA referencing Risperdal Consta meet certain requirements, 
including requirements related to demonstrating BE (Docket No. FDA-
2011-P-0086). FDA is reviewing the issues raised in the petition. FDA 
will consider any comments on the revised draft BE recommendations in 
responding to the 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 risperidone injection. 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 to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. 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.

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: May 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12847 Filed 5-26-15; 8:45 am]
 BILLING CODE 4164-01-P