www.fdanews.com/articles/100630-fabre-kramer-receives-decision-from-fda-on-gepirone-er-for-major-depressive-disorder
Fabre-Kramer Receives Decision From FDA on Gepirone ER for Major Depressive Disorder
November 5, 2007
Fabre-Kramer Pharmaceuticals Inc. (FKP) and GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) has issued a not approvable letter for the new drug application for gepirone extended- release (ER) tablets, submitted for the treatment of adults with major depressive disorder.
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