Ranbaxy gets FDA OK for dementia drug |
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Thu, 30 Aug 2007 19:13
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NEW YORK (AP) - India's Ranbaxy Laboratories Ltd. said Thursday the company received tentative approval from the U.S. Food and Drug Administration to make and market the generic version of dementia treatment Razadyne.The tentative approval provides Ranbaxy Pharmaceuticals Inc., the Jacksonville, Fla.-based subsidiary of Ranbaxy Laboratories, with 180 days of exclusivity to make and sell galantamine hydrobromide tablets at 4 milligrams, 8 milligrams and 12 milligrams.Galantamine hydrobromide, also known as Razadyne, is indicated for the treatment of mild to moderate dementia of the Alzheimer's type, according to Ranbaxy. The drug has annual sales of about $130 million.Razadyne, which is made by Janssen Pharmaceutica Inc., starts to go off patent Dec. 14, 2008, the date when RPI said it will launch the product upon final approval.Janssen Pharmaceutica is part of Johnson & Johnson's subsidiary Janssen LP, based in Titusville, N.J.Copyright 2007 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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Ranbaxy gets tentative FDA approval for making, marketing Galantamine in US 