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Valtrex transmission indication

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's Aug. 29 approval of GSK's Valtrex (valacyclovir) for reduction of the risk of heterosexual transmission of genital herpes in immunocompetent patients follows the Antiviral Drugs Advisory Committee's May 14 recommendation on restricting the patient population. GSK had been seeking a broader indication that did not specify sexual orientation or immune status. The company is developing a patient education brochure, to be available in October, emphasizing safe-sex practices with the use of Valtrex. FDA cleared the agent April 1 for suppression of recurrent genital herpes in HIV-infected patients (1Pharmaceutical Approvals Monthly April 1, 2003, In Brief)...
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