Ranbaxy Labs gets approval for Esomeorazole Magnesium capsules

Ranbaxy Laboratories Ltd on February 07, 2008 has announced that the Company has received tentative approval from the U.S. Food and Drug Administration for Esomeprazole Magnesium Delayed-Release Capsules, 20 mg (base) and 40 mg (base). Nexium® (Esomeprazole) is the second largest selling drug in USA with total annual market sales of $5.5 billion (IMS — MAT: December 2007).

Ranbaxy believes that it has a FTF (First to File) status on the drug, providing it with a potential 180 days marketing exclusivity, thereby offering a significant opportunity in the future.

Esomeprazole is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis, to maintain symptom resolution and healing of erosive esophagitis and for treatment of heartburn and other symptoms associated with Gastroesophageal Reflux Disease (GERD),.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of the Company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

Nexium® is the registered trademark of Astra Zeneca.