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Our Bureau

New Delhi, June 25 Ranbaxy Laboratories Ltd announced on Wednesday that the company has received tentative approval from the US Food and Drug Administration to manufacture and market generic version of Roche’s Valcyte used in treating patients with acquired immunodeficiency syndrome (AIDS).

Total annual market sales for the drug, chemically known as Valganciclovir Hydrochloride Tablets 450 mg, were $239 million.

“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,” said a press release. “Ranbaxy is pleased to receive this tentative approval for Valganciclovir Hydrochloride Tablets, a medicine that has established its clinical value and utility over time. It will be launched by Ranbaxy, upon receiving final approval and resolution of litigation currently pending in Federal District Court, as an affordably priced alternative to the branded product, Valcyte. This product formulation will further expand our portfolio of affordable generic alternatives and will be available to all classes of trade,” said Mr Bill Winter, Vic- President of Trade Sales for Ranbaxy Pharmaceuticals Inc, USA.

“This represents another potentially strong market entry for Ranbaxy medicines from among our pipeline of patent challenges, and offers us a significant future opportunity,” Mr Winter added

More Stories on : Regulatory Bodies & Rulings | Pharmaceuticals | Ranbaxy Laboratories Ltd

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