The Hindu Business Line : Ranbaxy gets FDA nod for anti-depressant

RANBAXY Laboratories Ltd has received approval from the US Food and Drug Administration (FDA) to manufacture and market Fluoxetine 40 mg capsules used for treating depressions.

Ranbaxy's formulation was found to be bioequivalent and has the same therapeutic effect as that of Eli Lilly and the company's Prozac 40 mg capsules.

The total market sales for Fluoxetine capsules and tablets were $534.0 million, with 40 mg capsules totalling $176.0 million.

Fluoxetine is indicated for treatment of major depressive disorder and obsessions and compulsions in patients with obsessive compulsive disorder as defined in the DSM-III R.

According to Mr Jim Meehan, Vice-President Sales and Marketing, Ranbaxy Pharmaceuticals Inc, "With the approval of Fluoxetine capsules we are now adding to our list of generic central nervous system 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."

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