PRINCETON, NJ (December 14, 2004) – Ranbaxy Laboratories Ltd. has received approval from the U.S. Food & Drug Administration (FDA) to manufacture and market Fluoxetine 40 mg capsules.
The FDA’s Office of Generic Drugs has determined the Ranbaxy formulations to be “bioequivalent and have the same therapeutic effect” as that of Eli Lilly & Co.’s Prozac 40 mg capsules, Ranbaxy said.
Fluoxetine is indicated for the treatment of major depressive disorder and of obsessions and compulsions in patients with obsessive-compulsive disorder, Ranbaxy said, as well as 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.
Ranbaxy will launch Fluoxetine in January 2005, according to Jim Meehan, vice president of sales and marketing for Ranbaxy Pharmaceuticals Inc., a wholly owned subsidiary of Ranbaxy Laboratories Ltd., India’s largest pharmaceutical company. Ranbaxy Pharmaceuticals, Jacksonville, FL, is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.