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news.Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has received FDA approval for its abbreviated new drug application (ANDA) for Valacyclovir Hydrochloride tablets, USP, in the 500 and 1000 mg strengths.
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Valacyclovir Hydrochloride is the generic equivalent to GlaxoSmithKline’s Valtrex tablets. Watson intends to begin shipping the product shortly.
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 pharmaceutical company engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women’s health.