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GSK’s Valtrex Clears FDA Cmte.; Herpes Transmission Endpoints Debated

Executive Summary

Clinical studies for genital herpes drugs intended to demonstrate a reduction in disease transmission should include seroconversion as a primary endpoint, FDA's Antiviral Drugs Advisory Committee agreed May 14

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Valtrex Safe-Sex Brochure In Development After Approval For Transmission

GlaxoSmithKline is creating a patient education brochure to be available in October that will emphasize safe-sex practices with the use of Valtrex

Valtrex Safe-Sex Brochure In Development After Approval For Transmission

GlaxoSmithKline is creating a patient education brochure to be available in October that will emphasize safe-sex practices with the use of Valtrex

Valtrex herpes transmission indication

GlaxoSmithKline's Valtrex (valacyclovir) clears FDA for reduction of the risk of heterosexual transmission of genital herpes when used as a suppressive therapy in combination with safer sex practices. The approval follows the recommendations of the Antiviral Drugs Advisory Committee during a May 14 meeting (1"The Pink Sheet" May 19, 2003, p. 14)...

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