Navigation Links
FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
Date:9/20/2007

- The Prescription Drug User Fee Act (PDUFA) user fee goal date will be

January 18, 2008 -

YARDLEY, Pa., Sept. 20 /PRNewswire/ -- Tibotec Pharmaceuticals Ltd. today announced that the New Drug Application (NDA) for TMC125 (etravirine), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), has been accepted for priority review by the United States Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) user fee goal date for the NDA for TMC125, the date by which the FDA must announce its decision regarding the application, will be January 18, 2008.

The NDA for TMC125, the first NNRTI to show antiviral activity in patients with documented NNRTI resistance, is based on the 24-week efficacy and safety results of two ongoing Phase III randomized, double-blinded, placebo- controlled studies, known as DUET-1 and DUET-2. The DUET studies examined the use of TMC125 in combination with other antiretroviral agents in adult treatment-experienced HIV-1 patients. The safety and efficacy of TMC125 in combination with other antiretroviral agents has not been established.

TMC125 is currently available through an expanded access program (EAP) in the United States, as well as a number of European countries and Canada. The EAP provides access to TMC125 to HIV-1 infected adults, at least 18 years old, who have limited treatment options either due to virological failure or intolerance to multiple ARV regimens. Patients must be three-class experienced, having received treatment from each of the three major oral classes of anti-HIV drugs (NRTIs, NNRTIs and PIs), unable to use currently approved NNRTIs due to resistance and/or intolerance and have received at least two PI-based regimens.

Pending U.S. regulatory approval, Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., will commercialize the product in the U.S. The trade name for the marketed product has not yet been det
'/>"/>

SOURCE Tibotec Pharmaceuticals Ltd.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Mexico Supreme Court Accepts Petition To Review Mexico City Law Legalizing Abortion During First Three Months Gestation
2. Novartis files application with FDA for Zometa
3. Morepan to file new drug applications with the USFDA
4. Mini motor for micromedical applications
5. Perfusion bioreactor could enhance stem cell research and application in the future
6. Prostate Cancer Can Be Treated By Application Of LASER Technology
7. Varied Applications of Adult Stem Cells to Treat Host of Disorders in Human
8. Venus Remedies Files 5th International Patent Application
9. NICE supports application of advanced biological therapies as treatment option for acute psoriasis
10. Roche puts in an Application to Use Herceptin for Treatment in Her-2 positive breast cancer
11. New Drug Application Submitted for Investigational Antibiotic Doripenem
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2014)... Ticket Down is a dependable source for authentic ... Sun Life Stadium in Miami on Monday, August 4th. ... and diehard soccer fans from the Miami, Florida area are ... Cup final in person at Sun Life Stadium. ... split into two groups where they will then play each ...
(Date:7/31/2014)... 2014 Dr. Mohebi was asked about ... the experience of traveling and sharing what we learned ... California. We are now witnessing results that we ... is our pleasure to communicate this knowledge to our ... ways of performing FUE transplantation helped inspire many other ...
(Date:7/31/2014)... 2014 A program for anyone looking ... the University of Colorado Anschutz Health and Wellness ... boot camp and transformation program. , “Extreme Weight ... Eyeworks USA, is an evidenced-based program inspired by the ... Eyeworks USA. This season, the show has participants spending ...
(Date:7/31/2014)... Flagstaff, AZ (PRWEB) July 31, 2014 ... long-term substance abuse treatment program in Flagstaff, AZ, learn ... an understanding of equipment and paddle strokes in preparation ... Juan River. , "I think that [the kayaking course] ... things that they struggle with in their early part ...
(Date:7/31/2014)... 2014 Parker Waichman, LLP, a national ... comments that whistleblowers are a critical component of the ... that may cause harm to consumers and may defraud ... Appreciation Day. , According to a 2013 report issued ... declared "National Whistleblower Appreciation Day" on July 30, 2013; ...
Breaking Medicine News(10 mins):Health News:Guinness International Champions Cup Finals Tickets in Miami, FL Available at Ticket Down 2Health News:Guinness International Champions Cup Finals Tickets in Miami, FL Available at Ticket Down 3Health News:Los Angles Hair Transplant Surgeon, Dr. Parsa Mohebi Inspires Doctors at Global Conferences to Adopt His Novel Method in FUE Hair Transplantation 2Health News:"Extreme Weight Loss: Destination Boot Camp" Comes to Colorado - The CU Anschutz Health and Wellness Center Begins Transformational Program 2Health News:"Extreme Weight Loss: Destination Boot Camp" Comes to Colorado - The CU Anschutz Health and Wellness Center Begins Transformational Program 3Health News:Back2Basics Substance Abuse Residents Take Kayaking Class for the First Time 2Health News:National Whistleblower Appreciation Day Declared to Ensure Recognition of Enormous Contribution to the Democracy by Whistleblowers, Parker Waichman LLP Comments 2Health News:National Whistleblower Appreciation Day Declared to Ensure Recognition of Enormous Contribution to the Democracy by Whistleblowers, Parker Waichman LLP Comments 3Health News:National Whistleblower Appreciation Day Declared to Ensure Recognition of Enormous Contribution to the Democracy by Whistleblowers, Parker Waichman LLP Comments 4
... /PRNewswire-FirstCall/-- Gentiva Health,Services, Inc., the nation,s leading provider ... it has promoted Thomas M. Boelsen to,Senior Vice ... to lead the Company,s ancillary,care benefit management unit ... members across the country. He was named to ...
... Strategic initiatives focus on healthy living, healthy aging, healthy ... ... today,announced a $30 million investment in three initiatives that will help,Silicon Valley ... to make significant strides in achieving the goals,of healthy living, healthy aging, ...
... city officials, efforts, questions Sutter,s intentions, SAN ... United Healthcare Workers - West (UHW), representing,1,200 caregivers ... expressed,serious doubts about the "Blue Ribbon Panel" announced ... to develop a plan for,the future of St. ...
... WASHINGTON, Jan. 24 The following was issued,by the ... Union Address:, As President Bush prepares to address ... American voters consistently cite health,care as a top domestic ... health care, there are also areas in need of ...
... CARLSBAD, Calif., Jan. 24 AutoGenomics, a leader ... it,has obtained clearance from the Food and Drug ... Warfarin. The company has already,received FDA clearance for ... "We are excited to receive FDA clearance ...
... treatments for diabetes, researchers say , , THURSDAY, Jan. 24 (HealthDay ... to locate stem cells in the pancreas -- in mice, ... humans, they could pave the way for dramatic new therapies ... body could once again produce its own insulin. Until now, ...
Cached Medicine News:Health News:Gentiva(R) Health Services Promotes Boelsen to Senior Vice President, CareCentrix(R) 2Health News:Gentiva(R) Health Services Promotes Boelsen to Senior Vice President, CareCentrix(R) 3Health News:The Health Trust Announces $30 Million Investment Towards Making Silicon Valley Healthiest Region in America 2Health News:The Health Trust Announces $30 Million Investment Towards Making Silicon Valley Healthiest Region in America 3Health News:Healthcare Workers Skeptical of Planning Process for St. Luke's 2Health News:AMA on the State of Health Care in Advance of the Presidential State of the Union Address 2Health News:AMA on the State of Health Care in Advance of the Presidential State of the Union Address 3Health News:Stem Cells Finally Found in Pancreas 2Health News:Stem Cells Finally Found in Pancreas 3
(Date:7/31/2014)... SAN FRANCISCO , July 31, 2014 /PRNewswire/ ... ) and Aspira Scientific ( Milpitas, California ... joint venture to develop and commercialize new fluorination ... biologically active molecules has benefited from the use ... metabolism, and combine lipophilicity with polarity to improve ...
(Date:7/31/2014)... For the first time, cardiac surgeons, medical ... the SynCardia temporary Total Artificial Heart in a peer ... the Journal of Visualized Experiments website. ... the SynCardia Total Artificial Heart implantation   goo.gl/2OZyKW ... the SynCardia Total Artificial Heart," a July 18, 2014 ...
(Date:7/31/2014)... , July 31, 2014 The Galien Foundation ... Prix Galien USA Awards. The ... accolade and recognizes the technical, scientific and clinical research ... This year brings the highest number of nominees ... USA . Nominees include biomedical products across three ...
Breaking Medicine Technology:Catylix, Inc. and Aspira Scientific Announce Joint Venture to Commercialize New Fluorination Technologies 2How to Implant the SynCardia Total Artificial Heart Detailed in Peer Reviewed Paper and Matching Video 2How to Implant the SynCardia Total Artificial Heart Detailed in Peer Reviewed Paper and Matching Video 3The Galien Foundation Announces 2014 Prix Galien USA Nominees for "Best Biotechnology Product," "Best Pharmaceutical Agent," and "Best Medical Technology" 2The Galien Foundation Announces 2014 Prix Galien USA Nominees for "Best Biotechnology Product," "Best Pharmaceutical Agent," and "Best Medical Technology" 3The Galien Foundation Announces 2014 Prix Galien USA Nominees for "Best Biotechnology Product," "Best Pharmaceutical Agent," and "Best Medical Technology" 4The Galien Foundation Announces 2014 Prix Galien USA Nominees for "Best Biotechnology Product," "Best Pharmaceutical Agent," and "Best Medical Technology" 5
... Verisk Health announced that it ... include greater predictive power and reporting capabilities. The product is ... of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) system. ... department (ED) utilization and measure practice variation for both commercial ...
... Oct. 17, 2011 The Radiosurgery Society™ (RSS), a ... science and clinical practice of stereotactic body radiotherapy (SBRT) ... February 23-25 at the La Costa Resort in Carlsbad, ... the newly-named Radiosurgery Society has been expanded to serve ...
Cached Medicine Technology:Verisk Health's DxCG Risk Solutions Technology Ready to Support Industry Adoption of ICD-10-CM 2Announcing The Radiosurgery Society™ And Its 2012 SRS/SBRT Scientific Meeting 2Announcing The Radiosurgery Society™ And Its 2012 SRS/SBRT Scientific Meeting 3
...
Anodized aluminum. Durable and lightweight with built-in protection against rust. Security locks ensure against accidental opening. Silicone matting/V-strips and bumper guards hold instruments in pla...
Diamond knife tray with silicone inserts to securely hold the diamond knife....
Size: 6 x 10 inches. Depth: 7 inches. Sterilizable plastic tray with silicone matting for supporting and protecting instruments....
Medicine Products: