Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Third 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, titled 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 August 27, 2026 (91 FR 55348), by an additional 6 months. The effective date of the May 2026 Notice, as previously extended to November 4, 2026, is hereby further extended to May 4, 2027. 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 209 (Friday, October 30, 2026)</title>
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[Federal Register Volume 91, Number 209 (Friday, October 30, 2026)]
[Notices]
[Page 68525]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22175]


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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; Third 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; third 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 
May 27, 2026, titled 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 August 27, 2026 (91 FR 55348), by 
an additional 6 months. The effective date of the May 2026 Notice, as 
previously extended to November 4, 2026, is hereby further extended to 
May 4, 2027. 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 May 4, 2027.

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. 5172, Silver Spring, MD 20993-0002, 301-
796-0061, <a href="/cdn-cgi/l/email-protection#0a4b67686f78244769416364666f734a6c6e6b24626279246d657c"><span class="__cf_email__" data-cfemail="5f1e323d3a2d71123c143631333a261f393b3e7137372c71383029">[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 the 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 (IRS) product, that is not the 
subject of an approved new drug application (NDA) or abbreviated new 
drug application (ANDA) would be unlawful as of June 26, 2026.
    FDA subsequently extended the effective date of the May 2026 Notice 
to September 24, 2026, and then to November 4, 2026, to allow the 
Agency sufficient time to consider issues raised by interested parties 
following publication of the May 2026 Notice. See 91 FR 38717 and 91 FR 
55348.

II. Third Extension of Effective Date

    FDA has determined that additional time is needed to fully consider 
the issues raised by interested parties. Accordingly, FDA is extending 
the effective date of the May 2026 Notice by an additional six months, 
from November 4, 2026, to May 4, 2027. See 21 CFR 314.200(h).

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-22175 Filed 10-29-26; 8:45 am]
BILLING CODE 4164-01-P


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