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news.Mylan Inc has announced that its subsidiary, Mylan Pharmaceuticals Inc has received final approval from the FDA for its abbreviated new drug application for fluoxetine capsules USP, 10 mg and 20 mg.
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Fluoxetine capsules, indicated for the treatment of premenstrual dysphoric disorder are the generic version of Eli Lilly’s Sarafem Pulvules capsules.
Currently, Mylan has 112 abbreviated new drug applications (ANDA) pending FDA approval, 23 of which are potential first-to-file opportunities.