Watson Pharmaceuticals, Inc. has announced that its subsidiary, Watson Laboratories, Inc., has received approval from the FDA on its Abbreviated New Drug Application (ANDA) for Valacyclovir Hydrochloride tablets, USP, in the 500 and 1000 mg strengths, the generic equivalent to GlaxoSmithKline, LLC’s VALTREX® tablets. Watson intends to begin shipping the product shortly.
VALTREX® 500 and 1000 mg had total U.S. sales of approximately $1.8 billion for the twelve months ending March 2010, according to IMS Health. Valacyclovir hydrochloride tablets are indicated for treatment of cold sores (herpes labialis), initial episodes of genital herpes in immunocompetent adults, recurrent episodes of genital herpes in immunocompetent adults, chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIV-infected adults, the reduction of transmission of genital herpes in immunocompetent adults, and the treatment of herpes zoster (shingles) in immunocompetent adults.
