Exxua
Generic name: gepirone
Treatment for: Major Depressive Disorder
Fabre-Kramer Refiles Gepirone ER with the FDA for the Treatment ofMajor Depressive Disorder
LONDON, PHILADELPHIA and HOUSTON, May 8, 2007 /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 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.
Source: GlaxoSmithKline
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
Web site: http://www.gsk.com/
http://www.fabrekramer.com/
Company News On-Call: http://www.prnewswire.com/comp/801350.html
Posted: May 2007
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- Fabre-Kramer Pharmaceuticals Announces FDA Acceptance of NDA Resubmission as Complete Response and Assignment of PDUFA Regulatory Action Date - January 24, 2023
- Fabre-Kramer Submits NDA Amendment for Exxua™ for Treatment of Major Depressive Disorder - January 4, 2023
- FDA Rules Favorably On Efficacy Of Travivo (Gepirone ER) For Treatment Of Major Depressive Disorder - March 17, 2016
- Fabre-Kramer Looks Forward to FDA's Decision on Gepirone ER for the Treatment of Major Depressive Disorder - December 2, 2015
- Fabre Kramer Pharmaceuticals Receives Decision From FDA on GepironeER for Major Depressive Disorder - November 5, 2007
Exxua (gepirone) FDA Approval History
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