[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66743-66744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26570]
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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Draft Guidance for Industry on Bioequivalence Recommendations for
Iron Sucrose; 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availability of a draft guidance for industry entitled ``Bioequivalence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 Iron Sucrose.'' The recommendations provide
specific guidance on the design of bioequivalence (BE) studies to
support abbreviated new drug applications (ANDAs) for iron sucrose
injection. The draft guidance is a revised version of a previously
issued draft guidance on the same subject.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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by January 6, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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, 7520 Standish
Pl., Rockville, MD 20855, 240-276-8866.
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 draft BE recommendations for iron sucrose injection
(Draft Iron Sucrose Injection BE Recommendations of 2013).
Venofer (iron sucrose injection), new drug application 021135, was
initially approved by FDA in November 2000. There are no approved ANDAs
for this product.
In March 2012, FDA posted on its Web site a draft guidance for
industry on the Agency's recommendations for BE studies to support
ANDAs for iron sucrose injection (Draft Iron Sucrose Injection BE
Recommendations of 2012). In that draft guidance, FDA recommended an in
vivo fasting BE study with pharmacokinetic endpoints and in vitro
studies. FDA has reconsidered the recommendations in the Draft Iron
Sucrose Injection BE Recommendations of 2012 and has decided to revise
it. At this time, FDA is withdrawing the Draft Iron Sucrose Injection
BE Recommendations of 2012 and is issuing a revised draft guidance for
industry, the Draft Iron Sucrose Injection BE Recommendations of 2013.
In this revised draft guidance, FDA recommends that for the in vivo
pharmacokinetic study the difference between total iron and
transferrin-bound iron be used to demonstrate BE of generic iron
sucrose injection products. FDA is no longer recommending baseline-
adjusted total iron and baseline-adjusted transferrin-bound iron be
used to demonstrate BE of generic iron sucrose injection products. The
revised draft guidance also provides updated information about the
recommended studies for in vitro characterization and criteria for
waiver of in vivo testing.
In March 2005, Luitpold Pharmaceuticals, Inc. (Luitpold),
manufacturer of the reference listed drug, Venofer, submitted (through
its attorneys) a citizen petition requesting that FDA withhold approval
of any ANDA or 505(b)(2) application for a generic iron sucrose
injection unless certain conditions were satisfied, including
conditions related to demonstrating BE (Docket No. FDA-2005-P-0319,
formerly 2005P-0095/CP1). FDA is reviewing the issues raised in the
petition and is also reviewing the supplemental information and
comments that have been submitted to the docket for that petition. FDA
will consider any comments on the Draft Iron Sucrose Injection BE
Recommendations of 2013 before responding to Luitpold'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 iron sucrose 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
[[Page 66744]]
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: October 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26570 Filed 11-5-13; 8:45 am]
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