Opportunity
Federal Register #2026-12933
FDA Notice: Extension of Effective Date for Drug Efficacy Study Implementation on Estrogen-Androgen Fixed-Combination Drug Products
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
June 26, 2026
Respond By
September 25, 2026
Identifier
2026-12933
This notice from the Food and Drug Administration (FDA), under the Department of Health and Human Services, announces an extension of the effective date for a previous resolution concerning drug efficacy study implementation for estrogen-androgen fixed-combination drug products. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Products Referenced: - Estrogen-androgen fixed-combination drug products - Includes Syntest D.S. Tablets and Syntest H.S. Tablets - The proceeding is not limited to these two products - OEMs and Vendors: - No specific OEMs or vendors are named in the notice - Notable Requirements: - These products lack substantial evidence of effectiveness for treating moderate to severe vasomotor symptoms associated with menopause in patients not improved by estrogen alone - Shipment in interstate commerce of any such product not covered by an approved new drug application (NDA) or abbreviated new drug application (ANDA) is unlawful - The extension allows the FDA additional time to consider issues raised by interested parties - No procurement or award is announced; this is a regulatory notice, not a solicitation
Description
This notice from the Food and Drug Administration (FDA) extends the effective date of a previous notice regarding the drug efficacy study implementation for estrogen-androgen fixed-combination drug products. The extension moves the effective date from June 26, 2026, to September 24, 2026, to allow the FDA additional time to consider issues raised by interested parties. The original notice concluded that certain 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 extension does not change the findings but delays the enforcement of the final resolution.