FDA Delays Again on Estrogen-Androgen Combo Drug Efficacy Final Call
Published Date: 8/27/2026
Notice
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, 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.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
FDA Finds Estrogen-Androgen Drugs Ineffective
In the May 27, 2026 notice (DESI 7661), FDA concluded that estrogen-androgen fixed-combination drug products lack substantial evidence of effectiveness for treating 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 such product not the subject of an approved NDA or ANDA would be unlawful as of the notice's effective date, which has now been set to November 4, 2026.
Effective Date Extended to November 4, 2026
The FDA is extending the effective date of its May 27, 2026 DESI 7661 notice by 41 days. The effective date was previously extended to September 24, 2026 and is now further extended to November 4, 2026 to allow FDA more time to consider issues raised by interested parties.
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