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U.S. FDA Approves New 60 mg Dosage Strength of Fluoxetine

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, Oct. 11, 2011 /PRNewswire/ -- Edgemont Pharmaceuticals, LLC, a neuroscience focused company, today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Fluoxetine Tablets 60 mg. Fluoxetine, originally marked in the U.S. under the brand name Prozac®, 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...

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