United States' Food and Drug Administration has granted approval to Ranbaxy Laboratories Ltd to manufacture and market 40 mg capsules of Fluoxetine, a drug used in treatment of obsessive-compulsive disorders.
The office of Generic Drugs of FDA has determined the formulations to be bio-equivalent and having the same therapeutic effect as that of the reference listed drug Prozac 40-mg capsules of Eli Lilly, Ranbaxy informed the Bombay Stock Exchange on Wednesday.
Fluoxetine is indicated for the treatment of major depressive disorder and obsessions and compulsions in patients with obsessive-compulsive disorder, it said.
The product is also indicated for treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa, it said.
Total market sales for Fluoxetine capsules and tablets were $534 million, with 40 mg capsules totaling $176 million, it added.