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news.Ranbaxy Laboratories has received tentative approval from the FDA to manufacture and market Valganciclovir hydrochloride tablets, 450mg.
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Ranbaxy believes that it has first-to-file status on Valganciclovir tablets, thereby providing a potential of 180-days of marketing exclusivity, offering a significant opportunity in the future.
Valganciclovir HCl tablets are indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome. Valganciclovir HCl is also indicated for the prevention of CMV disease in kidney, heart and kidney-pancreas transplant patients at high risk.
Bill Winter, vice president of trade sales of Ranbaxy pharmaceuticals, USA, said: “This represents another potentially strong market entry for Ranbaxy medicines from among our pipeline of patent challenges, and offers us a significant future opportunity.”