FDA approves Roxane Laboratories' Valacyclovir Hydrochloride Tablets ANDA

Roxane Laboratories, Inc. announced today the Abbreviated New Drug Application (ANDA) approval of Valacyclovir Hydrochloride Tablets 500mg and 1g as of May 24, 2010 by the Food and Drug Administration. Valacyclovir Hydrochloride Tablets are a nucleoside analogue DNA polymerase inhibitor indicated for use in adult patients for the following: Cold Sores (Herpes Labialis), Genital Herpes (treatment of initial or recurrent episodes in immunocompetent patients, suppression in immunocompetent or HIV-infected patients, and reduction of transmission), and Herpes Zoster. Valacyclovir Hydrochloride Tablets are also indicated for use in pediatric patients for the treatment of Cold Sores (Herpes Labialis). 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 Laboratories, Inc. Valacyclovir Hydrochloride Tablets 500mg and 1g, bottles of 30 are available for immediate shipment to wholesalers and pharmacies nationwide.

Roxane Laboratories' Valacyclovir Hydrochloride Tablets 500mg and 1g bottles of 30 are AB rated to VALTREX® (valacyclovir hydrochloride tablets).  Annual sales of Valacyclovir Hydrochloride Tablets 500mg and 1g are approximately $2.13 BN.

Source:

Roxane Laboratories, Inc.

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