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

cts to lacking substantial evidence of effectiveness for the treatment of moderate to severe vasomotor symptoms associated with menopause in patients not improved by estrogen alone. At the same time, FDA also issued a Notice of Opportunity for a Hearing (NOOH) to manufacturers and distributors of drug products affected by the notice, regarding FDA's determination that such products lacked substantial evidence of effectiveness for the treatment of moderate to severe vasomotor symptoms associated with menopause in patients not improved by estrogen alone. In response to the April 14, 2003, NOOH, two companies requested hearings: Syntho Pharmaceutical, Inc. (Syntho), 230 Sherwood Ave, Farmingdale, NY 11735, and Solvay Pharmaceuticals, since acquired by Abbott Laboratories, 100 Abbott Park Rd., Abbott Park, IL 60064. In response to the 2003 NOOH, Syntho filed a written notice of participation and request for a hearing on May 14, 2003, and submitted data in support of its hearing request on June 13, 2003. Syntho marketed Syntest D.S. (1.25 milligrams (mg) esterified estrogens/2.5 mg methyltestosterone) and Syntest H.S. (0.625 mg esterified estrogens/ 1.25 mg methyltestosterone), both labeled for use in treating moderate to severe vasomotor symptoms associated with the menopause in patients not improved by estrogen alone. In a letter dated January 31, 2011, FDA asked Syntho whether it