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Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection; Availability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The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled “Draft Guidance on Risperidone.” The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for risperidone injection.


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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 25, 2013.


Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201,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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit electronic comments on the draft guidance to Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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Kris Andre, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9326.

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I. Background

In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft guidance for industry entitled “Bioequivalence Recommendations for Specific Products,” which explained the process that would be used to make product-specific bioequivalence (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 BE recommendations and to provide a meaningful opportunity for the public to consider and comment on those recommendations. FDA finalized that guidance and announced its availability in the Federal Register of June 11, 2010 (75 FR 33311). This notice announces the availability of revised draft BE recommendations for risperidone injection.

New drug application 021346 for Risperdal Consta (risperidone) Long-Acting Injection was initially approved by FDA in October 2003. In February 2010, FDA issued a draft guidance for industry on BE recommendations for generic risperidone injection (Draft BE Recommendations for Risperidone Injection). FDA is now issuing a revised version of the Draft BE Recommendations for Risperidone Injection (Revised Draft BE Recommendations).

In February 2011, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. submitted a citizen petition requesting that FDA require that any ANDA referencing Risperdal Consta (risperidone) Long-Acting Injection 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 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 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 either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to 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

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: August 21, 2013.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2013-20696 Filed 8-23-13; 8:45 am]