[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Notices]
[Pages 77515-77516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30109]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369]
Bioequivalence Recommendations for Methylphenidate Hydrochloride
Extended-Release Oral Suspension; Draft Guidance for Industry;
Availability
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availability of a draft guidance for industry entitled ``Bioequivalence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 Methylphenidate Hydrochloride Extended-Release Oral
Suspension.'' The recommendations provide specific guidance on the
design of bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs) for methylphenidate hydrochloride (HCl) extended-
release oral suspension.
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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 23, 2015.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, 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section for electronic access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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. 4726, Silver Spring, MD 20993-0002,
240-402-7959.
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 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 methylphenidate HCl extended-release oral
suspension.
New drug application 202100 for Quillivant XR (methylphenidate HCl)
extended-release oral suspension was initially approved by FDA in
September 2012. There are no approved ANDAs for this product. FDA is
now issuing a draft guidance for industry on BE recommendations for
generic methylphenidate HCl extended-release oral suspension (Draft
Methylphenidate HCl Oral Suspension BE Recommendations).
In August 2014, Pfizer, Inc., manufacturer of the reference listed
drug, Quillivant XR, submitted a citizen petition requesting that FDA
establish certain BE requirements for any new drug product that
references Quillivant XR and seeks approval by means of demonstrating
BE to Quillivant XR (Docket No. FDA-2014-P-1269). FDA is reviewing the
issues raised in the 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 methylphenidate HCl extended-release
oral suspension. 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 to the Division of Dockets Management
(see ADDRESSES) either electronic or written
[[Page 77516]]
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: December 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30109 Filed 12-23-14; 8:45 am]
BILLING CODE 4164-01-P