LONDON, PHILADELPHIA and HOUSTON, May 8 /PRNewswire-FirstCall/ --
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
http://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 http://www.gsk.com.
SOURCE GlaxoSmithKline
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Related links:
http://www.gsk.com
http://www.fabrekramer.com
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CONTACT:
GlaxoSmithKline enquiries, US Product
Communications, Marc Meachem, +1-919-483-2839, or UK Media
enquiries, Philip Thomson, (020) 8047 5502, or Joss Mathieson,
(020) 8047 5502, or Gwenan White, (020) 8047 5502, or US Media
enquiries, Nancy Pekarek, +1-215-751-7709, or Alice Hunt,
+1-215-751-7709, or Mary Anne Rhyne, +1-919-483-2839, or European
Analyst-Investor, Anita Kidgell, (020) 8047 5542, or enquiries,
David Mawdsley, (020) 8047 5564, or Sally Ferguson, (020) 8047
5543, or US Analyst- Investor enquiries, Frank Murdolo,
+1-215-751-7002, or Tom Curry, +1-215-751-5419; or Fabre Kramer
enquiries, Edward H Koehler,Jr., Executive Vice President,
+1-713-975-6900
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