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Ranbaxy Gains US FDA Approval for Fluoxetine 40mg Capsules


NEW DELHI, India -- Dec. 15, 2004 -- Ranbaxy Laboratories Limited (RLL) announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Fluoxetine 40mg 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 40mg capsules of Eli Lilly and Company. Total market sales for Fluoxetine capsules and tablets were $534.0 million, with 40mg capsules totaling $176.0 million (IMS - MAT: September, 2004).

Fluoxetine is indicated for the treatment of major depressive disorder and obsessions and compulsions in patients with obsessive-compulsive disorder (OCD) as defined in the DSM-III R. The product is also indicated for the treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa and for 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. We anticipate launching the product in January, 2005,” according to Jim Meehan, Vice President of Sales and Marketing for RPI, USA.

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. 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.


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