Fabre-Kramer Refiles Gepirone ER with the FDA for the Treatment of Major Depressive Disorder

I said watch this space…

Tue, 08 May 2007 13:06:00 GMT

LONDON, PHILADELPHIA and HOUSTON — 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. Fabre-Kramer and GlaxoSmithKline entered an agreement in February of this year for collaboration on the worldwide development and commercialization of gepirone ER.

I’ve already written about Gepirone ER here, here and here.

I wonder if anyone we know was involved in the research…. watch this space!

One Response to “Fabre-Kramer Refiles Gepirone ER with the FDA for the Treatment of Major Depressive Disorder”

  1. Matthew Holford Says:

    Well, it’ll need something to replace Seroxat, I suppose.

    Matt


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