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news.Roxane Laboratories, a subsidiary of Boehringer Ingelheim, has received FDA approval for its abbreviated new drug application (ANDA) for Valacyclovir Hydrochloride tablets 500mg and 1g as of May 24, 2010.
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Valacyclovir Hydrochloride tablets are a nucleoside analogue DNA polymerase inhibitor indicated for use in adult patients for cold sores (Herpes Labialis), genital herpes and herpes zoster.
The efficacy and safety of Valacyclovir Hydrochloride tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.
Roxane said that Valacyclovir Hydrochloride tablets 500mg and 1g, bottles of 30 are available for immediate shipment to wholesalers and pharmacies nationwide.
Roxane claimed that its Valacyclovir Hydrochloride tablets 500mg and 1g bottles of 30 are AB rated to Valtrex (valacyclovir hydrochloride tablets).
Valtrex is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection.
Valtrex is a registered trademark of GlaxoSmithKline.