Gepirone ER Approval Status
- FDA approved: No
- Generic name: Gepirone ER
- Company: Fabre-Kramer Pharmaceuticals Inc. and GlaxoSmithKline
- Treatment for: Depression, Major Depressive Disorder
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, 2007||Fabre Kramer Pharmaceuticals Receives Decision From FDA on Gepirone ER for Major Depressive Disorder|
|May 8, 2007||Fabre-Kramer Refiles Gepirone ER with the FDA for the Treatment of Major Depressive Disorder|
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