Ranbaxy gets tentative nod for Galantamine
Ranbaxy Laboratories Ltd receives tentative approval from 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 $130mn (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”, according to Jim Meehan Vice President of Sales and Marketing for RPI.
“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” he said.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA, is a wholly owned subsidiary of the Company, India largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the US. healthcare system.
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