Document ID: FDA-2007-D-0369-0077
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose Injection; Availability
Posted Date: 2012-03-28T04:00Z

[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Notices]
[Pages 18827-18828]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7456]

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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Draft Guidance for Industry on Bioequivalence Recommendations for 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 Injection; 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availability of a draft guidance for industry entitled ``Bioequivalence 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.

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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 29, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: 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 draft BE recommendations for iron sucrose injection.
    Venofer (iron sucrose injection), new drug application 021135, was 
initially approved by FDA in November 2000. There are no approved ANDAs 
for this product. FDA is now issuing a draft guidance for industry on 
BE recommendations for generic iron sucrose injection (Draft Iron 
Sucrose Injection BE Recommendations).
    In March 2005, Luitpold Pharmaceuticals, Inc. (Luitpold), 
manufacturer of the reference listed drug (RLD), 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 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

[[Page 18828]]

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 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. 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 document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: March 22, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-7456 Filed 3-27-12; 8:45 am]
BILLING CODE 4160-01-P