Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2022-09737 · Docket No. FDA-2007-D-0369

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled “Draft Guidance for Testosterone.” The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to support abbreviated new drug applications (ANDAs) for testosterone pellet.

Dates

Submit either electronic or written comments on the draft guidance by July 5, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

Supplementary Information

I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products,” which explained the process that would be used to make product-specific guidances available to the public on FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs. As described in that guidance, FDA adopted this process to develop and disseminate product-specific guidances and to provide a meaningful opportunity for the public to consider and comment on the guidances. This notice announces the availability of a revised draft guidance on a generic testosterone pellet. FDA initially approved ANDA 080911 for TESTOPEL (testosterone pellet) in July 1972. FDA issued a draft guidance for industry on generic testosterone pellet in August 2011. We are now issuing a revised draft guidance for industry on generic testosterone pellet (“Draft Guidance for Testosterone”). In July 2012, Actient Pharmaceuticals, manufacturer, at that time, of TESTOPEL, ANDA 080911, 1 submitted a citizen petition requesting, among other things, that FDA refrain from approving any ANDA referencing TESTOPEL unless certain conditions are satisfied, including conditions related to demonstrating BE (Docket No. FDA-2012-P-0737, available at https://www.regulations.gov ). FDA is reviewing the issues raised in the petition and will consider any comments on the draft guidance entitled “Draft Guidance for Testosterone” before responding to the citizen petition. 1 ANDA 080911 for TESTOPEL is currently held by Endo Pharmaceuticals, Inc. This revised draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The revised draft guidance, when finalized, will represent the current thinking of FDA on the information and data to demonstrate BE to support ANDAs for testosterone pellet. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Dated: May 2, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022-09737 Filed 5-5-22; 8:45 am]