Notice: Draft Guidance for Industry on Bioequivalence Recommendations for
Fluticasone Propionate; Salmeterol Xinafoate; Availability
Federal Register: Volume 78, Number 175 (Tuesday, September 10, 2013)
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Bioequivalence
Recommendations for Fluticasone Propionate; Salmeterol Xinafoate.'' The
recommendations provide specific guidance on the design of
bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs) for fluticasone propionate; salmeterol xinafoate.
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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 12, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Bhawana Saluja, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-8465.
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
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 fluticasone propionate;
Advair Diskus (fluticasone propionate; salmeterol xinafoate), new
drug application 021077, was initially approved by FDA in August 2000.
There are no approved ANDAs for this product. FDA is now issuing a
draft guidance for industry on BE recommendations for generic
fluticasone propionate; salmeterol xinafoate (Draft Fluticasone
Propionate; Salmeterol Xinafoate BE Recommendations).
In December 2009, GlaxoSmithKline (GSK), manufacturer of the
reference listed drug Advair Diskus, submitted a citizen petition
requesting that FDA withhold approval of any ANDA or 505(b)(2)
application for generic oral inhalation products containing fluticasone
propionate and/or salmeterol xinafoate unless certain conditions were
satisfied, including conditions related to demonstrating BE (Docket No.
FDA-2009-P-0597). FDA is reviewing the issues raised in the petition.
FDA will consider any comments on the Draft Fluticasone Propionate;
Salmeterol Xinafoate BE Recommendations before responding to GSK's
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 fluticasone propionate; salmeterol
xinafoate. 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.
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
Dated: September 3, 2013.
Assistant Commissioner for Policy.
[FR Doc. 2013-21892 Filed 9-9-13; 8:45 am]
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