Mylan (MYL) Receives Final FDA Approval for Generic Version of Sarafem(R) Capsules
Mylan Inc. (NYSE: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Inc., received final approval from the U.S. FDA for its Abbreviated New Drug Application for Fluoxetine Capsules USP, 10 mg and 20 mg.
Fluoxetine Capsules, indicated for the treatment of premenstrual dysphoric disorder are the generic version of Eli Lilly's Sarafem(R) Pulvules(R) Capsules. This product had annual U.S. sales of approximately $19.2 million for the 12 months ending Sept. 30, 2008, for the noted strengths, according to IMS Health. Shipment of the product will begin immediately.
Mylan, Inc. and its subsidiaries engage in the development, manufacture, marketing, licensing, and distribution of generic, brand, and branded generic pharmaceutical products, as well as active pharmaceutical ingredients.
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