Ranbaxy receives tentative approval for Galantamine tablets

Aug 30 2007

Ranbaxy Laboratories Limited (RLL), has announced that the Company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Galantamine Hydrobromide Tablets, 4mg (base), 8mg (base), and 12mg (base).

Galantamine is indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Total annual market sales for Razadyne were $130.0 million (IMS - MAT: June 2007).

"This tentative approval will provide Ranbaxy Pharmaceuticals Inc. (RPI) with an opportunity to market this product and anticipate sharing in the period of 180 days exclusivity that will be beneficial to the Company, as well as to the U.S. healthcare system. We will launch the product upon final approval, which is anticipated on December 14, 2008. At the time of launch, product will be available immediately to all classes of trade," according to Jim Meehan, Vice President of Sales and Distribution for RPI.