[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73600-73601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29035]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]


Bioequivalence Recommendations for Budesonide Extended-Release 
Tablets; Draft Guidance for Industry; Availability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availability of a draft guidance for industry entitled ``Bioequivalence 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 Budesonide Extended-Release Tablets.'' The guidance 
provides specific recommendations on the design of bioequivalence (BE) 
studies to support abbreviated new drug applications (ANDAs) for 
budesonide extended-release tablets.

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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 9, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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 Andr[eacute], Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 75, Rm. 1615, Silver Spring, MD 20993-0002, 
240-402-7290.

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 to provide a meaningful opportunity for the public to consider and 
comment on those recommendations. This notice announces the 
availability of draft BE recommendations for budesonide extended-
release tablets.
    New drug application 203634 for UCERIS (budesonide) extended-
release tablets, 9 milligrams (mg), was initially approved by FDA in 
January 2013. FDA is now issuing a draft guidance for industry on BE 
recommendations for generic budesonide extended-release tablets.
    In February 2013, Santarus, Inc., submitted a citizen petition 
requesting that FDA: (1) Issue an individual BE guidance for budesonide 
extended-release tablets and (2) refrain from approving any ANDA that 
identifies UCERIS (budesonide) extended-release tablets as the 
reference listed drug unless the generic product is shown to be 
bioequivalent based on appropriate data from a clinical efficacy 
endpoint study, comparative pharmacokinetic testing, in vitro 
dissolution testing, and pharmacoscintigraphy studies (Docket No. FDA 
2013-P-0127). FDA reviewed the issues raised in the petition and is 
responding to the petition today in a letter that will be included in 
the citizen petition docket.
    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 budesonide extended-release tablets. 
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

[[Page 73601]]

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: December 5, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29035 Filed 12-10-14; 8:45 am]
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