Ranbaxy gets US FDA nod for galantamine hydrobromide tabs to manufacture and market
The Ranbaxy Laboratories has received tentative approval from the US 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. According to IMS – June 2007 total annual market sales for razadyne were $130.0 million
The shares of the Ranbaxy Laboratories gained over 1 per cent. The company will benefit from the 180 day shared exclusivity on the product which is being issued by the company on August 30, 2007.
According to Jim Meehan, vice president, sales and marketing, RPI this tentative approval provides an opportunity to market this product. The product will be launched after final approval, which is anticipated on December 14, 2008. Razadyne is a registered trademark of Janssen Pharmaceutica Inc.