FDA approves NDA for Edgemont's Fluoxetine 60 mg tablet

Oct 12 2011

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 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.

Patient therapy adherence remains a major clinical issue; approximately 40% of patients undergoing antidepressant therapy become non-compliant within three months of therapy initiation. Numerous published studies have also demonstrated a statistically significant improvement in patient therapy adherence when the number of pills per dose is reduced.

"By reducing the number of pills per dose from three pills to one, we are hopeful that our Fluoxetine 60 mg Tablets may help patients be more therapy compliant. This is an especially important goal for the higher milligram dose patients that may be having trouble controlling their symptoms of depression," said Douglas Saltel, President and CEO of Edgemont.

Edgemont's goal is to ensure broad patient access by aggressively pricing its Fluoxetine 60 mg Tablets in the range of generics. Edgemont expects to begin shipping product in approximately four weeks.