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Solvay Estratest Female Sexual Dysfunction Studies Could Save Product – FDA

Executive Summary

Solvay should provide studies supporting the use of Estratest (estrogen/methyltestosterone) for the treatment of female sexual dysfunction to keep the product on the market, FDA suggests

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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 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 Cleared From FDA Application Integrity Policy; Luvox Decision Pending

Solvay has been cleared from FDA's Application Integrity Policy list as of April 9

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