[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46965-46966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-18629]
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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Draft Guidance for Industry on Bioequivalence Recommendations for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.
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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availability of a draft guidance for industry entitled ``Bioequivalence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 The draft guidance is a revised version of a previously
issued draft guidance on the same subject.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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 1, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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]
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