FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: 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

WASHINGTON, May 27 -- Food and Drug Administration has issued a notice called: 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.

The notice was published in the Federal Register on May 27 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing that all outstanding hearing requests for estrogen-androgen fixed-combination drug products under Docket FDA-1998-P-0083 (formerly 76N-0377) (DESI 7661) have been withdrawn. Therefore, as proposed in the Ap...