
[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46965-46966]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18629]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Bioequivalence Recommendations for 
Mesalamine Rectal Suppositories; 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availability of a draft guidance for industry entitled ``Bioequivalence 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 Mesalamine.'' The recommendations provide specific 
guidance on the design of bioequivalence (BE) studies to support 
abbreviated new drug applications (ANDAs) for mesalamine rectal 
suppositories. The draft guidance is a revised version of a previously 
issued draft guidance on the same subject.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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 1, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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 a draft guidance on mesalamine (Draft Mesalamine Rectal 
Suppository BE Recommendations of 2013).
    CANASA (Mesalamine, USP) Rectal Suppositories, new drug application 
021252, 500 milligram (mg) and 1,000 mg strengths were approved by FDA 
in January 2001 and November 2004, respectively. The 500 mg strength is 
no longer marketed. There are no approved ANDAs for this product.
    In May 2007, FDA posted on its Web site a draft guidance for 
industry on the Agency's recommendations for BE studies to support 
ANDAs for mesalamine rectal suppositories (Draft Mesalamine Rectal 
Suppository BE Recommendations of May 2007). In that draft guidance, 
FDA recommended in vivo studies to demonstrate BE of generic mesalamine 
rectal suppositories: A BE study with clinical endpoints and a fasting 
BE study with pharmacokinetic endpoints. FDA has reconsidered the 
recommendations in the Draft Mesalamine Rectal Suppository BE 
Recommendations of May 2007 and has decided to revise it. In March 
2013, FDA withdrew the Draft Mesalamine Rectal Suppository BE 
Recommendations of May 2007 and posted on its Web site a revised draft 
guidance for industry, the Draft Mesalamine Rectal Suppository BE 
Recommendations of 2013. In this revised draft guidance, FDA recommends 
in vivo and in vitro studies to demonstrate BE of generic mesalamine 
rectal suppositories: A fasting BE study with pharmacokinetic endpoints 
and comparative in vitro studies (melting point, differential scanning 
calorimetry, density, and viscosity). FDA is no longer

[[Page 46966]]

recommending a BE study with clinical endpoints for demonstration of BE 
of generic mesalamine rectal suppositories.
    In July 2007, Axcan Scandipharm (Axcan), manufacturer of CANASA, 
submitted a citizen petition requesting that FDA withhold approval of 
any ANDA application for a generic version of CANASA (mesalamine rectal 
suppositories) unless certain studies that demonstrated BE were 
conducted (Docket No. FDA-2007-P-0010, formerly 2007P-0302/CP1). FDA is 
reviewing the issues raised in the petition and is also reviewing the 
supplemental information submitted to the docket for this petition. FDA 
will consider any comments on the Draft Mesalamine Rectal Suppository 
BE Recommendations of 2013 before responding to Axcan'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 mesalamine rectal suppositories. 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 electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18629 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P


