Draft Guidance for Industry on Bioequivalence Recommendations for Rifaximin Tablets; Availability, 7585-7586 [2012-3234]
Download as PDF
<![CDATA[
Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on this topic. 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
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). In the draft
guidance, FDA advises drug and
medical device manufacturers who
receive and use crude heparin to
manufacture drugs and medical devices
to notify the Agency of crude heparin
found to contain any amount of OSCS
(for human drugs 21 CFR
314.81(b)(1)(ii); for animal drugs 21 CFR
514.80(b); for medical devices 21 CFR
803.50). The collections of information
in 21 CFR 314.81(b)(1)(ii) have been
approved under OMB control number
0910–0001; in 21 CFR 514.80(b) under
OMB control number 0910–0284; and in
21 CFR 803.50 under OMB control
number 0910–0437.
erowe on DSK2VPTVN1PROD with NOTICES
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm,
https://www.fda.gov/MedicalDvices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm, or
https://www.regulations.gov.
14:46 Feb 10, 2012
[FR Doc. 2012–3229 Filed 2–10–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
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.
VerDate Mar<15>2010
Dated: February 8, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Jkt 226001
Draft Guidance for Industry on
Bioequivalence Recommendations for
Rifaximin Tablets; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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.
SUMMARY:
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 https://
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.
ADDRESSES:
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
7585
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 productspecific BE recommendations available
to the public on FDA’s Web site at
https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm. As
described in that guidance, FDA
adopted this process as a means to
develop and disseminate productspecific 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 rifaximin200 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 rifaximin550 (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 Rifaximin200 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
E:\FR\FM\13FEN1.SGM
13FEN1
7586
Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices
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 rifaximin200 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
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
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]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2007–D–0369]
Draft Guidance for Industry on
Bioequivalence Recommendation for
Nitroglycerin Metered Spray/
Sublingual Products and Metered
Aerosol/Sublingual Products;
Availability
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of two draft guidances for
industry entitled ‘‘Bioequivalence
Recommendations for Nitroglycerin,’’
one for nitroglycerin metered spray/
sublingual products and one for
nitroglycerin metered aerosol/
sublingual products. The
erowe on DSK2VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
14:46 Feb 10, 2012
Jkt 226001
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 https://
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:
ADDRESSES:
I. Background
Food and Drug Administration
AGENCY:
recommendations provide specific
guidance on the design of
bioequivalence (BE) studies to support
abbreviated new drug applications
(ANDAs) for these products. The draft
guidances are revised versions of
previously published draft guidances on
the 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 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.
In the Federal Register sof 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 https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm. As
described in that guidance, FDA
adopted this process as a means to
develop and disseminate productspecific BE recommendations and
provide a meaningful opportunity for
the public to consider and comment on
those recommendations. This document
announces the availability of two
revised draft BE recommendations, one
for nitroglycerin metered spray/
sublingual products and one for
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
nitroglycerin metered aerosol/
sublingual products.
Nitrolingual Pumpspray (nitroglycerin
lingual spray), approved by FDA in
October 1985, is a metered dose spray
indicated for acute relief of an attack or
prophylaxis of angina pectoris due to
coronary artery disease. Nitromist
(nitroglycerin lingual aerosol), approved
by FDA in November 2006, is another
metered dose spray indicated for acute
relief of an attack or acute prophylaxis
of angina pectoris due to coronary artery
disease. Nitrolingual Pumpspray and
Nitromist are designated as reference
listed drugs (RLDs), and therefore any
ANDAs for generic nitroglycerin lingual
spray or generic nitroglycerin lingual
aerosol must demonstrate BE to the
relevant RLD prior to approval. There
are no approved ANDAs for these
products.
In February 2010, FDA posted on its
Web site a draft guidance for industry
on the Agency’s recommendations for
BE studies to support ANDAs for
nitroglycerin metered spray/sublingual
products (Draft Nitroglycerin Spray BE
Recommendations of February 2010). In
that draft guidance, FDA recommended
three studies to demonstrate BE of
generic nitroglycerin metered spray/
sublingual products: An in vivo fasting
study, an in vitro study of unit dose and
uniformity of unit dose, and an in vitro
study of priming and tail off.
In March 2010, FDA posted on its
Web site a draft guidance for industry
on the Agency’s recommendations for
BE studies to support ANDAs for
nitroglycerin metered aerosol/
sublingual products (Draft Nitroglycerin
Aerosol BE Recommendations of March
2010). In that draft guidance, FDA
recommended three studies to
demonstrate BE of generic nitroglycerin
metered aerosol/sublingual products:
An in vivo fasting study, an in vitro
study of unit dose and uniformity of
unit dose, and an in vitro study of
priming and tail off.
FDA has reconsidered the
recommendations for both of these draft
guidances and has decided to revise
them. In November 2011, FDA
withdrew the Draft Nitroglycerin Spray
BE Recommendations of February 2010
and the Draft Nitroglycerin Aerosol BE
Recommendations of March 2010. FDA
is now issuing revised draft guidances
for industry on BE recommendations for
nitroglycerin metered spray/sublingual
products (Revised Draft Nitroglycerin
Spray BE Recommendations) and
nitroglycerin metered aerosol/
sublingual products (Revised Draft
Nitroglycerin Aerosol BE
Recommendations). In these revised
draft guidances, FDA recommends one
E:\FR\FM\13FEN1.SGM
13FEN1
]]>Agencies
[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Notices]
[Pages 7585-7586]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3234]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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]
BILLING CODE 4160-01-P
