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:2/8/2016)... and FAIRFIELD, N.J. , ... and Medimetriks Pharmaceuticals, Inc. (Medimetriks) today announced that they ... development and commercialization rights for OPA-15406 in the U.S. ... also provides manufacturing rights.  OPA-15406 is a topical, non-steroidal ... atopic dermatitis. --> --> ...
(Date:2/8/2016)... -- --> --> ... Market by Product (Radiofrequency, Ultrasound, Irreversible Electroporation, Cryotherapy, Microwave) ... Gynecology) - Global Forecasts to 2020", published by MarketsandMarkets, ... period of 2015 to 2020. The market is expected ... 10.5% from 2015 to 2020. Browse 73 ...
(Date:2/8/2016)... , Feb. 8, 2016 In a historic vote among its ... to construct a medical cannabis cultivation facility and dispensary on tribal land ... New York as a provider for patients in the state,s ... as a provider for patients in the state,s Medical Cannabis ... (34) to approve the project and pursue designation from the ...
Breaking Medicine Technology:
(Date:2/8/2016)... ... February 08, 2016 , ... Delta Dental of California and ... pancreatic cancer. , Gary D. Radine, who recently retired as president and CEO of ... Society’s 2015 CEO of the Year , helped lead the effort to raise ...
(Date:2/8/2016)... ... February 08, 2016 , ... Eating disorders and post-traumatic stress ... women and men with eating disorders report a history of trauma, research suggests ... of an eating disorder. , At the 2016 iaedp Symposium, the workshop, ...
(Date:2/8/2016)... ... February 08, 2016 , ... GrassrootsHealth published data from ... type 2 diabetes in the GrassrootsHealth cohort with substantially higher vitamin D levels ... in public health,” states Carole Baggerly, Director of GrassrootsHealth, “the safety and ...
(Date:2/8/2016)... ... February 08, 2016 , ... Joshua ... on how healthcare companies can use newly released government data on populations and ... population and intervene and capture the value they create to succeed in new ...
(Date:2/8/2016)... ... February 08, 2016 , ... According to research ... U.S. require dental technicians to be certified or obtain continuing education. To increase ... the “What’s In Your Mouth?” campaign to inform dentists and patients about the ...
Breaking Medicine News(10 mins):