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Bioequivalence Recommendations for Risperidone; Draft Guidance for Industry; Availability

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on risperidone injection entitled “Draft Guidance on Risperidone.” The recommendations provide specific guidance on the design of studies to support abbreviated new drug applications (ANDAs) for risperidone injection. This draft guidance is the second revision of a previously issued draft guidance on the same subject.


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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 27, 2015.


Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit electronic comments on the draft guidance to Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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Xiaoqiu Tang, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-796-5850.

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​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific bioequivalence (BE) recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. This notice announces the availability of a second revision of draft BE recommendations for risperidone injection.

FDA initially approved new drug application 021346 for Risperdal Consta Long-Acting Injection in October 2003. There are no approved ANDAs for this product. In February 2010, FDA issued a draft guidance for industry on BE recommendations for generic risperidone injection. In August 2013, we issued a revised draft guidance on the same subject. We are now issuing a second revision of the draft guidance for industry on BE recommendations for generic risperidone injection (Draft Guidance on Risperidone).

In February 2011, Johnson & Johnson Pharmaceutical Research and Development, LLC, manufacturer of Risperdal Consta, the reference listed drug, submitted a citizen petition requesting that FDA require that any ANDA referencing Risperdal Consta meet certain requirements, including requirements related to demonstrating BE (Docket No. FDA-2011-P-0086). FDA is reviewing the issues raised in the petition. FDA will consider any comments on the revised draft BE recommendations in responding to 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 risperidone injection. 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 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​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm or

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Dated: May 21, 2015.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2015-12847 Filed 5-26-15; 8:45 am]