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Notice: Draft Guidance for Industry on Bioequivalence Recommendations for 
Fluticasone Propionate; Salmeterol Xinafoate; Availability
Federal Register: Volume 78, Number 175 (Tuesday, September 10, 2013)
                  Pages 55263-55264

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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availability of a draft guidance for industry entitled ``Bioequivalence 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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 12, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

[[Page 55264]]


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 fluticasone propionate; 
salmeterol xinafoate.
    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 
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 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.

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: September 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21892 Filed 9-9-13; 8:45 am]
BILLING CODE 4160-01-P


 
 
 

 
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