FDA Gives Ranbaxy Shingles Drug Final Approval
Posted on: Thursday, 1 February 2007, 15:01 CST
India-based Ranbaxy Pharmaceuticals has received final approval from the FDA to market valacyclovir hydrochloride tablets in 500mg and 1g.
The FDA's Division of Bioequivalence has determined the Ranbaxy formulation to be bioequivalent and therapeutically equivalent to Valtrex Caplets, developed by GlaxoSmithKline.
Valacyclovir HCl is indicated for the treatment of herpes zoster or shingles, for the treatment or suppression of genital herpes in immunocompetent individuals, and for the suppression of recurrent genital herpes in HIV-infected individuals. Valacyclovir HCl is also indicated for the treatment of cold sores.
"Valacyclovir is a product that will further expand our ever-growing portfolio of affordable generic alternatives in the anti-infective arena, and we are pleased to receive final approval from the US FDA. We anticipate that our generic formulation of valacyclovir hydrochloride tablets will provide benefits to the US healthcare system, including both prescribers and patients," said Jim Meehan, vice president of sales and marketing for Ranbaxy Pharmaceuticals.
Source: Datamonitor
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