Navigation Links
Fabre Kramer Pharmaceuticals Receives Decision From FDA on Gepirone ER for Major Depressive Disorder
Date:11/2/2007

HOUSTON, LONDON and RESEARCH TRIANGLE PARK, N.C., Nov. 2 /PRNewswire/ -- Fabre-Kramer Pharmaceuticals Inc. (FKP) and GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has issued a not approvable letter for the new drug application for gepirone extended- release (ER) tablets, submitted for the treatment of adults with major depressive disorder.

The FDA had previously reviewed Phase I through III clinical data involving gepirone ER. In June 2004, the FDA requested an additional positive short-term trial in order to consider gepirone ER for approval as a new antidepressant treatment. Subsequently, FKP successfully conducted a trial in patients with major depressive disorder to respond to the FDA request for an additional positive pivotal study.

Those results were submitted to the FDA in May 2007. The not approvable letter issued today is based on the FDA review of those additional results along with other newly submitted and previously submitted data.

Fabre-Kramer and GlaxoSmithKline entered an agreement in February of this year for collaboration on the worldwide development and commercialization of gepirone extended-release tablets. Fabre-Kramer and GSK are evaluating the response from the FDA to determine appropriate next steps.

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
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Inspiration Biopharmaceuticals Presents Data From Hemophilia Program at International Society On Thrombosis and Haemostasis (ISTH) Annual Meeting
2. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
3. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
4. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
5. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
6. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
7. EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
8. Pro-Pharmaceuticals Updates Progress of Clinical Trials & Davanat 505 (b)(2) Filings
9. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
10. Portola Pharmaceuticals Announces Positive Phase II EXPERT Results and Additional Oral and Poster Presentations at the XXI Congress of the International Society on Thrombosis and Haemostasis (ISTH)
11. Keryx Biopharmaceuticals, Inc. Announces Positive Phase I and Phase II Data on KRX-0401 in Patients with Relapsed/Refractory Multiple Myeloma and Waldenstroms Macroglobulinemia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/30/2016)... The global  parenteral nutrition ... by 2024, according to a new report by ... the growing malnutrition coupled with the prevalence of ... diseases are expected to boost the market over ... http://photos.prnewswire.com/prnh/20150105/723757 ) , The presence ...
(Date:5/30/2016)... - DCGI grants limited approval to market Stempeucel® product for treating ... becomes 5th off-the-shelf Stem cell product to be approved by a ... (also known as Thromboangiitis Obliterans) is a major unmet medical need ... Prevalence of Buerger,s Disease is estimated to be 1,000,000 in ... European Community & USA Stempeutics ...
(Date:5/30/2016)... 2016 Eye expert s ... to seek an eye examination before ...   Moorfields Eye Hospital Dubai, the first overseas ... , has identified premature babies as a special concern in ... particular vulnerability to retinopathy of prematurity (ROP). ROP is a potentially ...
Breaking Medicine Technology:
(Date:5/31/2016)... Atlanta, GA (PRWEB) , ... May 31, 2016 ... ... avoidable readmissions using a mix of advanced Artificial Intelligence (AI) and the latest ... predictive solution. The medical center is integrating predictive analytic outputs directly into the ...
(Date:5/31/2016)... MN (PRWEB) , ... May 31, 2016 , ... DDL, ... the American Association for Laboratory Accreditation (A2LA) to include ISO 594-1 and ISO 594-2 ... common means of achieving a leak-free connection between two medical devices (e.g. a syringe ...
(Date:5/31/2016)... ... May 31, 2016 , ... Spartan Bioscience ... enables unprecedented portability and convenience. , The Cube is exceptionally small—it takes up ... the Cube fits easily into any space, whether in a hospital, doctor’s office, ...
(Date:5/31/2016)... ... May 31, 2016 , ... The successful implementation of ... their laboratories as well. However, laboratories have different challenges compared to manufacturing environments. ... operations in the lab, METTLER TOLEDO has developed the Lean Lab Checklist . ...
(Date:5/31/2016)... ... May 31, 2016 , ... The Global Wellness ... released ten predictions on the future of wellness, travel, spa and beauty in Europe. ... spa and beauty companies to leading economists and researchers - to forecast where wellness ...
Breaking Medicine News(10 mins):