Fabre-Kramer refiles gepirone ER with the FDA for the treatment of major depressive disorder

Issued — Tuesday 8 May 2007, London, UK, Philadelphia, PA & Houston, TX

 

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 www.fabrekramer.com.

About GlaxoSmithKline

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For more information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com.

GlaxoSmithKline enquiries:

US Product Communications

Marc Meachem

(919) 483-2839

 

 

 

UK Media enquiries:

Philip Thomson

(020) 8047 5502

 

Joss Mathieson

(020) 8047 5502

 

Gwenan White

(020) 8047 5502

 

 

 

US Media enquiries:

Nancy Pekarek

(215) 751 7709

 

Alice Hunt

(215) 751 7709

 

Mary Anne Rhyne

(919) 483 2839

 

 

 

European Analyst/
Investor enquiries:

Anita Kidgell

(020) 8047 5542

 

David Mawdsley

(020) 8047 5564

 

Sally Ferguson

(020) 8047 5543

 

 

 

US Analyst/
Investor enquiries:

Frank Murdolo

(215) 751 7002

 

Tom Curry

(215) 751 5419

 

Fabre Kramer enquiries:

Edward H Koehler,Jr.
Executive Vice President

 

(713) 975 6900

 

This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.