
[Federal Register Volume 77, Number 215 (Tuesday, November 6, 2012)]
[Notices]
[Pages 66621-66622]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27004]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0433; (formerly Docket No. 2007D-0169)]


Draft Guidance for Industry on Bioequivalence Recommendation for 
Lenalidomide Capsules; 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availability of a draft guidance for industry entitled ``Draft Guidance 
on Lenalidomide.'' The guidance provides specific recommendations on 
the design of bioequivalence (BE) studies to support abbreviated new 
drug applications (ANDAs) for lenalidomide capsules. The draft guidance 
is a revised version of a previously published draft guidance on the 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draft guidance before it begins work on the final versions of the 
guidance, submit either electronic or written comments on the draft 
guidance by January 7, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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, ``Bioequivalence 
Recommendations for Specific Products,'' which explained the process 
that would be used to make

[[Page 66622]]

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 
revised draft BE recommendations for lenalidomide capsules.
    Revlimid (lenalidomide capsules), approved by FDA on December 27, 
2005, is a thalidomide analogue indicated for the treatment of: 
Multiple myeloma, in combination with dexamethasone, in patients who 
have received at least one prior therapy and also in patients with 
transfusion-dependent anemia due to low- or intermediate-1-risk 
myelodysplastic syndromes associated with a deletion 5q abnormality 
with or without additional cytogenetic abnormalities. Revlimid is 
designated as the reference listed drug, and therefore any ANDAs for 
generic lenalidomide capsules must demonstrate BE to the Revlimid prior 
to approval. There are no approved ANDAs for this product.
    In June 2010, FDA posted on its Web site a draft guidance for 
industry on the Agency's recommendations for BE studies to support 
ANDAs for lenalidomide capsules. In that draft guidance, FDA 
recommended studies in the 15 milligram (mg) and 25 mg strengths of 
lenalidomide capsules to demonstrate BE. FDA has now determined that a 
BE study in the 15 mg strength is unnecessary and is revising the 
guidance to remove that recommendation. FDA also is revising the 
guidance to recommend that a request for a waiver of in vivo testing be 
submitted for the 2.5 mg, 5 mg, 10 mg, and 15 mg strengths based on: 
(1) Acceptable fasting and fed bioequivalence studies on the 25 mg 
strength, (2) proportional similarity of the formulations across all 
strengths, and (3) acceptable in vitro dissolution testing of all 
strengths.
    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 lenalidomide capsules. 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 either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. 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 documents at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: October 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27004 Filed 11-5-12; 8:45 am]
BILLING CODE 4160-01-P


