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Cytomegalovirus
Ranbaxy Gains Tentative Approval to Manufacture and Market Valganciclovir Hydrochloride Tablets
July 12th, 2008
Ranbaxy Laboratories Limited (RLL), announced that the company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Valganciclovir Hydrochloride Tablets, 450 mg. Total annual market sales for Valganciclovir HCl Tablets were $239 million (IMS - MAT: March 2008). 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 (AIDS)....
Source: Law & Health Weekly (2008-07-12)
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