PRINCETON, N.J., June 25 Ranbaxy Laboratories Limited(RLL), announced today that the company has received tentative approval fromthe U.S. Food and Drug Administration to manufacture and market ValganciclovirHydrochloride Tablets, 450 mg. Total annual market sales for ValganciclovirHCl Tablets were $239 million (IMS - MAT: March 2008).
Ranbaxy believes that it has First-to-File status on Valganciclovirtablets, 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 ofcytomegalovirus (CMV) retinitis in patients with acquired immunodeficiencysyndrome (AIDS). Valganciclovir HCl is also indicated for the prevention ofcytomegalovirus (CMV) disease in kidney, heart and kidney-pancreas transplantpatients at high risk (Donor CMV seropositive/Recipient CMV seronegative[(D+/R-)]).
"Ranbaxy is pleased to receive this tentative approval for ValganciclovirHydrochloride Tablets, a medicine that has established its clinical value andutility over time. It will be launched by Ranbaxy upon receiving finalapproval and resolution of litigation currently pending in Federal DistrictCourt, as an affordably priced alternative to the branded product, Valcyte.This product formulation will further expand our portfolio of affordablegeneric alternatives and will be available to all classes of trade," said BillWinter, Vice President of Trade Sales for RPI, USA. "This represents anotherpotentially strong market entry for Ranbaxy medicines from among our pipelineof patent challenges, and offers us a significant future opportunity," Winteradded.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA, isa wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India'slargest pharmaceutical company. RPI is engaged in the sale and distributionof generic and branded prescription products in the U.S. healthcare system.
Ranbaxy Laboratories Limited, India's largest pharmaceutical company, isan integrated, research based, international pharmaceutical company producinga wide range of quality, affordable generic medicines, trusted by healthcareprofessionals and patients across geographies. Ranbaxy's continued focus onR&D has resulted in several approvals in developed markets and significantprogress in New Drug Discovery Research. The Company's foray into Novel DrugDelivery Systems has led to proprietary "platform technologies," resulting ina number of products under development. The Company is serving its customersin over 125 countries and has an expanding international portfolio ofaffiliates, joint ventures and alliances, ground operations in 49 countriesand manufacturing operations in 11 countries.* Valcyte(R) is a registered trademark of Roche Chuck Caprariello Vice President, Corporate Communications and Government Affairs Ranbaxy Inc. (609) 720-5615 Edwige Buteau RF Binder (212) 994-7517 Caroline Dickson RF Binder (212) 994-7560
SOURCE Ranbaxy Laboratories Limited