Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Second Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is extending the effective date of the notice published in the Federal Register on May 27, 2026, entitled "Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661" (91 FR 31462) (the "May 2026 Notice"), as previously extended by the notice published in the Federal Register on June 26, 2026 (91 FR 38717) (the "June 2026 Notice"), by an additional 41 days. The effective date of the May 2026 Notice, which was previously extended to September 24, 2026, is hereby further extended to November 4, 2026. This further extension is necessary to allow FDA sufficient time to consider issues raised by interested parties.

Full Text

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<title>Federal Register, Volume 91 Issue 165 (Thursday, August 27, 2026)</title>
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[Federal Register Volume 91, Number 165 (Thursday, August 27, 2026)]
[Notices]
[Pages 55348-55349]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-17498]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1998-P-0083 (formerly 76N-0377); DESI 7661]


Drugs for Human Use; Drug Efficacy Study Implementation: 
Estrogen-Androgen Fixed-Combination Drug Products; Second Extension of 
Effective Date of Final Resolution of Drug Efficacy Study 
Implementation 7661

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice; second extension of effective date.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is extending 
the effective date of the notice published in the Federal Register on

[[Page 55349]]

May 27, 2026, entitled ``Drugs for Human Use; Drug Efficacy Study 
Implementation: Estrogen-Androgen Fixed-Combination Drug Products; 
Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; 
Final Resolution of Drug Efficacy Study Implementation 7661'' (91 FR 
31462) (the ``May 2026 Notice''), as previously extended by the notice 
published in the Federal Register on June 26, 2026 (91 FR 38717) (the 
``June 2026 Notice''), by an additional 41 days. The effective date of 
the May 2026 Notice, which was previously extended to September 24, 
2026, is hereby further extended to November 4, 2026. This further 
extension is necessary to allow FDA sufficient time to consider issues 
raised by interested parties.

DATES: The effective date of the May 27, 2026, notice (91 FR 31462), as 
previously extended, is further extended to November 4, 2026.

ADDRESSES: For access to the docket to read background documents or the 
electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500 between 9 a.m. and 4 p.m., 
Monday through Friday. Publicly available submissions may be seen in 
the docket.
    The most relevant background documents regarding this matter are 
available in the docket. However, additional background documents are 
available upon request (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Amber McKinley, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5171, Silver Spring, MD 20993-0002, 301-
796-0061, <a href="/cdn-cgi/l/email-protection#8fcee2edeafda1c2ecc4e6e1e3eaf6cfe9ebeea1e7e7fca1e8e0f9"><span class="__cf_email__" data-cfemail="d998b4bbbcabf794ba92b0b7b5bca099bfbdb8f7b1b1aaf7beb6af">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    On May 27, 2026, FDA published a notice in the Federal Register (91 
FR 31462) announcing the final resolution of Drug Efficacy Study 
Implementation (DESI) 7661 for estrogen-androgen fixed-combination drug 
products. The May 2026 Notice concluded that all outstanding hearing 
requests for estrogen-androgen fixed-combination drug products under 
Docket FDA-1998-P-0083 had been withdrawn, and that such products lack 
substantial evidence of effectiveness for the treatment of moderate to 
severe vasomotor symptoms associated with menopause in patients not 
improved by estrogen alone. The May 2026 Notice stated that shipment in 
interstate commerce of any drug product identified in the docket, or 
any identical, related, or similar product, that is not the subject of 
an approved new drug application or abbreviated new drug application 
would be unlawful as of June 26, 2026.
    On June 26, 2026, FDA published a notice in the Federal Register 
(91 FR 38717) extending the effective date of the May 2026 Notice by 90 
days, from June 26, 2026, to September 24, 2026, to allow FDA 
sufficient time to consider issues raised by interested parties 
following publication of the May 2026 Notice.

II. Second Extension of Effective Date

    FDA has determined that additional time is needed in order to fully 
consider the issues raised by interested parties. Accordingly, FDA is 
extending the effective date of the May 2026 Notice by an additional 41 
days, from September 24, 2026, to November 4, 2026.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-17498 Filed 8-26-26; 8:45 am]
BILLING CODE 4164-01-P


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