Solvay requests FDA hearing regarding Estratest

Solvay requests hearing with FDA regarding its combination estrogen/methyltestosterone product Estratest and its pending ANDA for Estratest H.S. The company is responding to an April 14 notice in the Federal Register that announced FDA's proposal to withdraw the vasomotor symptoms indication for all androgen/estrogen combination agents. The agency is encouraging manufacturers to provide data about new uses, such as female sexual dysfunction, in order to keep the products on the market (1"The Pink Sheet" April 14, 2003, p. 17)...

Solvay requests hearing with FDA regarding its combination estrogen/methyltestosterone product Estratest and its pending ANDA for Estratest H.S. The company is responding to an April 14 notice in the Federal Register that announced FDA's proposal to withdraw the vasomotor symptoms indication for all androgen/estrogen combination agents. The agency is encouraging manufacturers to provide data about new uses, such as female sexual dysfunction, in order to keep the products on the market (¹ (Also see "Solvay Estratest Female Sexual Dysfunction Studies Could Save Product – FDA" - Pink Sheet, 14 Apr, 2003.), p. 17)....