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Ranbaxy Laboratories Gains U.S. FDA Approval For Fluoxetine 40mg Capsules


10/19/2005 5:12:28 PM

PRINCETON, N.J., Dec. 14 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received approval from the U.S. Food and Drug Administration to manufacture and market Fluoxetine 40 mg capsules. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Prozac 40 mg capsules of Eli Lilly and Company. Total annual market sales for Fluoxetine capsules and tablets were $534.0 million, with 40 mg capsules totaling $176.0 million (IMS - MAT: September, 2004).

Fluoxetine is indicated for the treatment of major depressive disorder. It is also indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD) as defined in the DSM-III R. Fluoxetine is indicated for the treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa. It is also indicated for the treatment of panic disorders with or without agoraphobia, as defined in DSM-IV.

"With the approval of Fluoxetine capsules, we are now adding to our list of generic CNS products that have proven value and utility in the treatment of psychiatric disorders that will now be available as an affordable generic alternative to the brand. Ranbaxy will launch Fluoxetine in January 2005," according to Jim Meehan, Vice President of Sales and Marketing for RPI.

Ranbaxy Pharmaceuticals Inc. ("RPI") based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited ("RLL"), India's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, manufactures and markets brand and generic pharmaceuticals and Active Pharmaceutical Ingredients. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. Ranbaxy's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies" resulting in a number of products under development. The Company is selling its products in over 100 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 34 countries and manufacturing operations in 7 countries.

*Prozac (R) is a registered trademark of Eli Lily and Company

Ranbaxy Pharmaceuticals Inc.

CONTACT: Charles M. Caprariello, Vice President, Business Development ofRanbaxy Inc., +1-609-720-5615; Janine Savarese of RF Binder Partners,+1-212-994-7525, for Ranbaxy


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