This PDF is the current document as it appeared on Public Inspection on 12/23/2014 at 08:45 am.
Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension.”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.
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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 23, 2015.
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Kris André, 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.End Further Info End Preamble Start Supplemental Information
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.
Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written Start Printed Page 77516comments 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.Start Signature
Dated: December 18, 2014.
Associate Commissioner for Policy.
[FR Doc. 2014-30109 Filed 12-23-14; 8:45 am]
BILLING CODE 4164-01-P