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. Fabre-Kramer and GlaxoSmithKline entered an agreement in February of this year for collaboration on the worldwide development and commercialization of gepirone ER. About Fabre-Kramer Pharmaceuticals Fabre-Kramer Pharmaceuticals, headquartered in Houston, Texas is engaged in acquiring, developing and commercializing psychotropic drugs that have significant market potential. In addition to gepirone ER, Fabre-Kramer has 10 other compounds in various stages of development for indications including depression, anxiety, schizophrenia, Parkinson's disease and insomnia. For more information, visit FKP's website at

(Author: http://www.fabrekramer.com)

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