Teva Granted Approval for Fluoxetine Capsules
May 22, 2008
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.
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.