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 treatment for the treatment of adults with major depressive disorder. In November 2007, the FDA issued a Not Approvable Letter for gepirone.
FDA Approval Status 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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