Mylan: FDA tentatively approves generic Sarafem Pulvules Capsules for premenstrual disorder

By Lisa Kerner

Charlotte, N.C., Aug. 30 - The Food and Drug Administration granted tentative approval to Mylan Laboratories Inc.'s Abbreviated New Drug Application for Fluoxetine Capsules, USP, 10mg and 20mg for the treatment of premenstrual dysphoric disorder, according to a company news release.

Mylan's capsules are the AB-rated generic version of Eli Lilly and Co.'s Sarafem Pulvules Capsules, which had U.S. sales of $52 million for the 12 months ended June 30.

Pittsburgh, Pa.-based Mylan develops, licenses, manufactures, markets and distributes generic and proprietary pharmaceutical products.

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