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Gepirone ER Approval Status

Gepirone extended-release (ER) is an investigational azapirone antidepressant for the treatment of adults with major depressive disorder.

In November 2007, Fabre-Kramer Pharmaceuticals Inc. announced the receipt of a Not Approvable Letter from the FDA, advising the company that the New Drug Application (NDA) for gepirone extended-release (ER) tablets had not been approved.

Development Status and FDA Approval Process for Gepirone ER

Nov  5, 2007Fabre Kramer Pharmaceuticals Receives Decision From FDA on Gepirone ER for Major Depressive Disorder
May  8, 2007Fabre-Kramer Refiles Gepirone ER with the FDA for the Treatment of Major Depressive Disorder

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