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12 Oct 2011

FDA Approves NDA for Fluoxetine Tablets 60 mg

The U.S. FDA has approved a New Drug Application (NDA) for Fluoxetine Tablets 60 mg.

The U.S. FDA has approved a New Drug Application (NDA) for Fluoxetine Tablets 60 mg submitted by neuroscience focused company Edgemont Pharmaceuticals.


Fluoxetine is a treatment for Major Depressive Disorder, Obsessive Compulsive Disorder in adults and pediatrics, and Bulimia Nervosa and Panic Disorder in adults.


The 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.


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