Watson Pharmaceuticals, Inc. announced that its subsidiary, Watson Laboratories, Inc, has received approval from the United States Food and Drug Administration 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 US sales of approximately US$ 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.
Watson Pharmaceuticals is a leading global specialty pharmaceutical company. The company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women's health.