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
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; ...
Food and Drug Administration, Health and Human Services (HHS).
ACTION:
Notice; second extension of effective date.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is extending the effective date of the notice published in the
Federal Register
on
( printed 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
www.regulations.gov
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,
Amber.McKinley@fda.hhs.gov.
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.
Use this for formal legal and research references to the published document.
91 FR 55348
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“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,” thefederalregister.org (August 27, 2026), https://thefederalregister.org/documents/2026-17498/drugs-for-human-use-drug-efficacy-study-implementation-estrogen-androgen-fixed-combination-drug-products-second-extensio.
www.regulations.gov