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news.Teva Pharmaceutical Industries has announced that the FDA has granted final approval for the company's abbreviated new drug application for Fluoxetine capsules USP, 10mg and 20mg.
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As the first company to file an abbreviated new drug application containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
Teva’s Fluoxetine capsules are the AB-rated generic equivalent of Eli Lilly’s Sarafem Pulvules, and are indicated for the treatment of premenstrual dysphoric disorder.