[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Notices]
[Pages 7585-7586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3234]
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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Draft Guidance for Industry on Bioequivalence Recommendations for
Rifaximin Tablets; 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 two draft guidances for industry entitled
``Bioequivalence Recommendations for Rifaximin,'' one for the 200-
milligram (mg) strength (rifaximin-200) and one for the 550-mg strength
(rifaximin-550). The recommendations provide specific guidance on the
design of bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs) for rifaximin tablets.
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 comment on the
draft guidances before it begins work on the final versions of the
guidances, submit either electronic or written comments on the draft
guidances by April 13, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidances 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access to the draft guidance documents.
Submit electronic comments on the draft guidances 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: Doan T. Nguyen, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-8608.
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 two draft BE recommendations, one for rifaximin-200 and
one for rifaximin-550.
Xifaxan (rifaximin) 200-mg tablets, approved by FDA in May 2004,
are indicated for the treatment of patients (>= 12 years of age) with
travelers' diarrhea caused by noninvasive strains of Escherichia coli.
Xifaxan (rifaximin) 550-mg tablets, approved by FDA in March 2010, are
indicated for reduction in risk of hepatic encephalopathy recurrence in
patients >= 18 years of age. Xifaxan, 200 mg, and Xifaxan, 550 mg, are
designated the reference listed drugs (RLDs) and therefore any ANDAs
for generic rifaximin-200 or rifaximin-550 must demonstrate BE to the
relevant RLD prior to approval. There are no approved ANDAs for these
products.
In November 2011, FDA posted on its Web site a draft guidance for
industry on the Agency's recommendations for BE studies to support
ANDAs for rifaximin-200 (Draft Rifaximin-200 BE Recommendations). FDA
is now issuing a draft guidance for industry on BE recommendations for
generic rifaximin-550 (Draft Rifaximin-550 BE Recommendations).
In May 2008, Salix Pharmaceuticals, Inc. (Salix), manufacturer of
the RLD, Xifaxan (200 mg), filed a citizen petition requesting that FDA
refuse to receive for substantive review, or approve, ANDAs for generic
rifaximin-200 unless the ANDAs contain certain data to demonstrate BE
(Docket No. FDA-2008-P-0300). FDA is reviewing the issues raised in the
petition and will consider any comments on the Draft Rifaximin-200 BE
Recommendations before responding to Salix's citizen petition and
finalizing its BE recommendations for rifaximin-200.
These draft guidances are being issued consistent with FDA's good
[[Page 7586]]
guidance practices regulation (21 CFR 10.115). The draft guidances,
when finalized, will represent the Agency's current thinking on the
design of BE studies to support ANDAs for rifaximin-200 and rifaximin-
550. They do not create or confer any rights for or on any person and
do 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. It is no
longer necessary to send two copies of mailed 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 documents at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: February 7, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3234 Filed 2-10-12; 8:45 am]
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