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,
'/>"/>

SOURCE GlaxoSmithKline
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2

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:9/23/2014)... YORK , September 23, 2014 ... pioneer in computer-aided dysmorphology analysis will exhibit at the ... Diego, CA. FDNA will present the latest ... and reference solution, using facial analysis technology. Face2Gene facilitates ... of human malformations from facial photos. The ...
(Date:9/23/2014)... -- According to the new research ... Irreversible Electroporation, Cryotherapy, Microwave), Application (General & Cosmetic ... to 2019", published by MarketsandMarkets, studies the global Ablation ... to 2019. The market is expected to reach ... from 2014 to 2019. Browse 95 ...
(Date:9/23/2014)... Sept. 23, 2014  While proton therapy recently began in the ... Ashya King , another case in the United States ... young boy who was given just days to live now looks forward ... Green of Arizona complained of a headache ... medical treatments that will conclude Sept. 23, when he completes proton ...
Breaking Medicine Technology:FDNA to Exhibit at ASHG2014 Presenting Face2Gene Integrated With London Medical Databases (LMD) Online 2Ablation Technologies Market Worth $3.81 Billion by 2019 2Ablation Technologies Market Worth $3.81 Billion by 2019 3Ablation Technologies Market Worth $3.81 Billion by 2019 45-Year-Old Brain Cancer Patient Completes Proton Therapy, Awaits Kindergarten 25-Year-Old Brain Cancer Patient Completes Proton Therapy, Awaits Kindergarten 35-Year-Old Brain Cancer Patient Completes Proton Therapy, Awaits Kindergarten 4
... with Betaseron(R),(interferon beta-1b) shortly after their first clinical ... risk of developing confirmed disability,progression compared to patients ... and published in The Lancet this,week-provide the first ... on later accumulation of disability, as observed,over the ...
... PHILADELPHIA, Aug. 3 GlaxoSmithKline (NYSE:,GSK), one of ... has placed another order to purchase bulk H5N1 ... The company also announced the,start of the first ... pre-pandemic influenza program. HHS Order The ...
Cached Medicine Technology:Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression 2Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression 3Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression 4Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression 5GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSK's Candidate Pre-pandemic Flu Vaccine to Start. 2GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSK's Candidate Pre-pandemic Flu Vaccine to Start. 3GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSK's Candidate Pre-pandemic Flu Vaccine to Start. 4
(Date:9/23/2014)... If you or a loved one ... treatment may be a challenge. Fortunately, an inventor from ... is designed to improve the experience. , He developed ... having to remove, tear or reposition their clothing. Furthermore, ... their dignity. At the same time, it safeguards their ...
(Date:9/23/2014)... been shown to be a driving force behind ... develops due to chronic inflammation caused by conditions ... relatively few effective treatment options. Now, scientists at ... for the first time in preclinical studies that ... astrocyte elevated gene-1 (AEG-1) halts the development and ...
(Date:9/23/2014)... Becker's Hospital Review has published ... Hospitals and Health Systems With Great Orthopedic Programs." ... the list have orthopedic surgery departments, programs or ... reputable sources. Exceptional orthopedic departments include physicians who ... and treat professional athletes. , This is the ...
(Date:9/23/2014)... the curve of oxygen desaturation" (AUC Desat ) may ... levels during procedures using sedation, according to a study ... AUC Desat provides information not only whether blood ... duration, and rate of episodes of oxygen desaturation. ... of Cincinnati and colleagues reports on the development of ...
(Date:9/23/2014)... Contrary to what is often assumed about single parents, ... from The Kinsey Institute has found that single parents ... active as often as singles without children -- and ... The study, "Dating and Sexual Behavior Among Single Parents ... online in the Journal of Sex Research ...
Breaking Medicine News(10 mins):Health News:Apparel for Dialysis Patients Invented by InventHelp Client (CBA-2492) 2Health News:Study uncovers genetic driver of inflammation, uses it to prevent and treat liver cancer 2Health News:125 Hospitals With Great Orthopedic Programs 2Health News:125 Hospitals With Great Orthopedic Programs 3Health News:125 Hospitals With Great Orthopedic Programs 4Health News:125 Hospitals With Great Orthopedic Programs 5Health News:New measure provides more data on oxygen levels during sedation 2Health News:Kinsey study of single parents' dating, sexual activity contradicts assumptions 2
... vascular disease - a blood circulation problem that causes ... Saxton and other researchers from Sheffield Hallam University's centre ... patients aged between 50 and 85 with peripheral vascular ... cardiovascular function and walking ability of the patients improved ...
... HIV/AIDS spread – says Governor, Mr S C Jamir. ... the spread of HIV/AIDS, Governor adds. ,Many labourers ... tourist spot, bring with them the dreadful virus (HIV) when they ... Chinese proposal named ‘Four Frees and One Care’ meaning free anti-retroviral ...
... a vaccine to protect themselves from cervical cancer as the ... American pharmaceutical giant Merck. // ,The Food and ... for use in girls and women ages 9 to 26 ... of products with potential to provide significant benefits. , ...
... fertility treatment do not confide in their employers about the ... a survey carried out by the Infertility Network of ... observed that the patients were worried about not being able ... survey, done for National Infertility Day, revealed that although ...
... 1918 pandemic hit, the death toll was so overwhelming that ... to hold brief //memorial services, trains commandeered to transport dead ... Philadelphia. ,With the threat of another flu pandemic ... and health care providers making preparations for it mortuary specialists ...
... A new study in UK reports, parents believe more than ... one year old children are found //to avoid certain foods ... compulsion - Dr. Taraneh Dean of the University of Portsmouth ... Journal of Allergy and Clinical Immunology as only 2 – ...
Cached Medicine News:Health News:What to do with the Dead if a Flu Outbreak Happens? 2
... for the Humphrey Field Analyzer, SITA ... shows less inter-test variability than Full ... of reproducibility as Full Threshold SWAP. ... with the earlier glaucoma damage detected ...
... you can trust its capabilities will ... cataract, and glaucoma therapy in one ... is the optimal system for photocoagulation, ... iridotomy. The push of a button ...
... The VISUCAM non-mydriatic ... quality and simplicity of ... big enough to set ... photography, it features a ...
... YAG III is the new disruption ... in particular for applications in posterior ... the YAG laser is also used ... IOL polishing. It's another milestone in ...
Medicine Products: