Mylan Laboratories Inc. announced that the U.S. Food and Drug Administration has granted tentative approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for fluoxetine capsules, USP, 10mg and 20mg.
Fluoxetine capsules are indicated for the treatment of premenstrual dysphoric disorder (PMDD). They are the AB-rated generic version of Eli Lilly and Company's Sarafem Pulvules Capsules, which had annual U.S. sales of approximately $52 million for the 12 months ending June 30, 2006.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries: Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.
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