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.