Federal Register #2026-17498

FDA Notice: Extension of Effective Date for Estrogen-Androgen Drug Products Regulation

This FDA notice addresses regulatory action for estrogen-androgen fixed-combination drug products: - Government buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - No OEMs or vendors are named; the notice is not a procurement opportunity - Products/services requested: - No products or services are being requested or procured - Notable requirements: - The FDA is extending the effective date for regulatory action on these drug products - Interstate shipment of these products without approved applications will be unlawful after the new effective date - The extension allows the FDA to consider issues raised by interested parties regarding effectiveness - No purchase quantities, part numbers, or procurement details are provided

Description

This notice from the Food and Drug Administration (FDA) announces a second extension of the effective date for the final resolution of Drug Efficacy Study Implementation 7661 concerning estrogen-androgen fixed-combination drug products. The extension moves the effective date to November 4, 2026, allowing the FDA additional time to consider issues raised by interested parties. The original notice concluded that these 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 notice also states that shipment in interstate commerce of such products without approved applications would be unlawful as of the effective date.

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