Edgemont Pharmaceuticals has reported that the FDA has approved its New Drug Application (NDA) for Fluoxetine tablets 60 mg.

Fluoxetine, originally marked in the U.S. under the brand name ProzacR, has become a widely-known and used treatment for major depressive disorder, obsessive compulsive disorder in adults and pediatrics, and bulimia nervosa and panic disorder in adults.

Edgemont's Fluoxetine 60 mg tablet is the only Fluoxetine product to offer a 60 mg dose in a single pill. The tablets also have a functional score to allow for a convenient half-tablet 30 mg dosing option. Until now, patients requiring a 30 mg or 60 mg dose of Fluoxetine have needed to take three 10 mg pills or three 20 mg pills to achieve their target dose.