Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on paliperidone palmitate extended-release injectable suspension entitled “Draft Guidance on Paliperidone Palmitate.” The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for paliperidone palmitate extended-release injectable 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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 29, 2016.
You may submit comments as follows:
Submit electronic submissions in the following way:
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• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
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• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions: To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th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
Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, rm. 4730, Silver Spring, MD 20993-0002, 301-796-5850.
In the
As described in that guidance, FDA adopted this process 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 paliperidone palmitate extended-release injectable suspension. FDA initially approved new drug application 022264 for INVEGA SUSTENNA (paliperidone palmitate) extended-release injectable suspension. There are no approved ANDAs for this product. In August 2011, we issued a draft guidance for industry on BE recommendations for paliperidone palmitate extended-release injectable suspension, which we subsequently revised in December 2013. We are now issuing a further revised draft guidance for industry on BE recommendations for generic paliperidone palmitate extended-release injectable suspension (“Draft Guidance on Paliperidone Palmitate”).
In May 2013, Janssen Research and Development, LLC, manufacturer of the reference listed drug, INVEGA SUSTENNA, submitted a citizen petition requesting that FDA require that any ANDA referencing INVEGA SUSTENNA extended-release injectable suspension meet certain conditions related to demonstrating BE (Docket No. FDA-2013-P-0608). FDA is reviewing the issues raised in the petition. FDA will consider any comments on the Draft Guidance on Paliperidone Palmitate 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 paliperidone palmitate extended-release injectable suspension. It does not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons with access to the Internet may obtain the document at either