GSK Valtrex gains indication, another pending
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
GlaxoSmithKline's Valtrex (valacyclovir) clears FDA for suppression of recurrent genital herpes in HIV-infected patients April 1. FDA's Antiviral Drugs Advisory Committee will consider another supplemental indication for Valtrex May 14 - use as suppressive therapy to reduce the risk of transmitting genital herpes. GSK submitted the risk reduction sNDA Oct. 31, 2002 and expects a standard revie
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