Ranbaxy Laboratories Limited (RLL) has received approval from the US Food and Drug Administration to manufacture and market Fluoxetine 40mg capsules, a company release said.
The Office of Generic Drugs, US 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 totalling $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 behaviours 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.