Fabre-Kramer Refiles Gepirone ER With The FDA For The Treatment Of Major Depressive Disorder

Fabre- Kramer Pharmaceuticals Inc. and GlaxoSmithKline announced today the submission by Fabre-Kramer to the Food and Drug Administration of an amendment to the New Drug Application for gepirone extended release (ER). The amendment responds to the FDA’s June 2004 request for an additional positive short term efficacy trial for gepirone ER. Fabre-Kramer is seeking marketing approval of gepirone ER for the treatment of major depressive disorder. [click link for full article]

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Filed under: Depression on May 9th, 2007