GLAXO VALTREX PROMOTIONS CONTAINING UNAPPROVED DOSE REGIMENS DRAW FDA INQUIRY; REVIEW OF FORMULARY KIT FOCUSED ON BIOAVAILABILITY COMPARISON TO ZOVIRAX
Executive Summary
FDA is satisfied with Glaxo Wellcome's efforts to correct Valtrex (valacyclovir) promotions that included reference to unapproved dose regimens for herpes management, the Division of Drug Marketing, Advertising & Communications informed the company in a recent letter.