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

Official 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.