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FDA gives tentative approval for Fluoxetine

The FDA has granted tentative approval for Mylan Pharmaceuticals' abbreviated new drug application for Fluoxetine capsules - a generic version of Eli Lilly's Sarafem Pulvules capsules.

Fluoxetine capsules are indicated for the treatment of premenstrual dysphoric disorder (PMDD). The disorder causes severe depression, bad mood swings and tension before menstruation.

Eli Lilly’s Sarafem pulvules capsules had annual US sales of approximately $52 million for the 12 months ending June 30, 2006.

Mylan Laboratories is a leading pharmaceutical company with three principal subsidiaries: Mylan Pharmaceuticals, Mylan Technologies and UDL Laboratories. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.

Mylan Laboratories recently acquired up to a 71.5% controlling interest in Matrix Laboratories, one of the worlds leading API developers.