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:12/17/2014)... -- Expectant parents should leave prenatal picture-taking to medical ... Use of ultrasound imaging and heartbeat monitors to get ... agency warns. "Although there is a lack ... and heartbeat monitors, prudent use of these devices by ... FDA biomedical engineer, said in an agency news release. ...
(Date:12/17/2014)... HealthDay Reporter , TUESDAY, Dec. 16, ... America, and work commitment is a big reason why, new ... said Dr. Mathias Basner, an assistant professor of sleep and ... of Medicine. A time-use survey of nearly 125,000 Americans, ... main activity exchanged for sleep. Short sleepers -- those who ...
(Date:12/15/2014)... 15, 2014 South Florida’s leading urgent care ... can be a daze of hassle, hustle, and bustle that ... decking halls, to burns when making special meals and heartburn ... can happen at any time. To prevent this season of ... made a list of helpful and healthful holiday tips to ...
(Date:12/15/2014)... News) -- Expert pilots process visual information more efficiently ... better decisions during landings, a new study shows. ... pilots to master, and 36 percent of all airplane ... final approach and landing. Researchers monitored the brain ... pilots while they were at the controls of a ...
(Date:12/15/2014)... 15, 2014 At the leading, long-established ... AutismOne and Focus Autism will welcome ... research on the effects of toxins to children’s health, ... information. , Luminaries such as Dr. Lucija Tomljenovic ... with esteemed, credentialed colleagues of the United States to ...
Breaking Medicine News(10 mins):Health News:FDA Warns Against Fetal 'Keepsake' Videos 2Health News:Work Steals Valuable Sleep Time, Study Finds 2Health News:Work Steals Valuable Sleep Time, Study Finds 3Health News:MD Now Urgent Care Presents Healthy Holiday Tips 2Health News:MD Now Urgent Care Presents Healthy Holiday Tips 3Health News:Study Shows Why Expert Pilots Are Experts 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 3
... Use ... device and length of time indoor tanning is used, according to a report in Cancer ... ... Cancer Research Hosted Press Conference on Findings, , ,(recording available below) , , , ...
... worked in people and pigs in study, but more ... A new approach to treating irregular heartbeats appears to ... both patients and pigs, new research indicates. , In ... laser-balloon catheter" -- enables doctors to much more accurately ...
... oral hygiene and cardiovascular disease , THURSDAY, May 27 ... teeth regularly: People who don,t perform this essential of ... heart disease compared to their more diligent peers. ... toothbrushing frequency and both cardiovascular disease and inflammatory markers ...
... , ... Dallas Salutes Ten Years of Continuous Addiction Treatment Services! , ... Dallas, Texas (PRWEB) -- Surrounded by friends ... “We look forward to ten more years” sings Dallas native Don Fielding, owner and ...
... ,central line, catheter-linked illnesses fall 18 percent across the ... across the United States are seeing a decrease of ... necks, called central line catheters, a new report finds. ... and public health problem in the United States," Dr. ...
... Science University is partnering with the University of Oregon and ... and existing drugs and compounds that may prevent the complications ... to bone marrow failure and cancer. With a new ... Institute, a branch of the NIH, the research teams will ...
Cached Medicine News:Health News:Indoor Tanning Beds Increase Risk of Melanoma 2Health News:Indoor Tanning Beds Increase Risk of Melanoma 3Health News:Indoor Tanning Beds Increase Risk of Melanoma 4Health News:Laser Used to Blast Away Cells Causing Irregular Heartbeat 2Health News:Toothbrushing May Stave Off Heart Woes 2Health News:Addiction and Recovery: Life Force Dallas 2Health News:Addiction and Recovery: Life Force Dallas 3Health News:Addiction and Recovery: Life Force Dallas 4Health News:Decline in Potentially Lethal Hospital-Based Infections 2Health News:Decline in Potentially Lethal Hospital-Based Infections 3Health News:OHSU joins forces with UO, Harvard to accelerate Fanconi anemia research 2Health News:OHSU joins forces with UO, Harvard to accelerate Fanconi anemia research 3
(Date:12/17/2014)... 17, 2014  Strategic Health Services, Inc. (SHS), a ... announced a strategic agreement with QualCare, Inc., a leading provider ... regional marketplace.  This agreement will further QualCare,s ... wellness solutions QualCare brings to its clients in ... QualCare plans cover more than 800,000 ...
(Date:12/17/2014)... MILAN , December 17, 2014 ... becoming nothing less than a hub of information concerning the ... A further addition to the recently launched ... world and has now been enriched by a new chapter ... A richly detailed and panoramic hub on ...
(Date:12/17/2014)... and RALEIGH, N.C. ... Marketing Communications, LLC (CTMC), and Integrated Clinical Trial ... recruitment and retention for clinical trials announce that ... Clinical Trial Marketing Services (i-CTMS). i-CTMS will provide ... services to pharmaceutical, biotechnology and medical device companies. ...
Breaking Medicine Technology:Strategic Health Services to collaborate with QualCare on Population Health and Wellness Technology for QualCare Members 2Strategic Health Services to collaborate with QualCare on Population Health and Wellness Technology for QualCare Members 3Dompé Offers a New "Window" on the World of Scientific Research, with the http://www.dompetrials.com Website, Dedicated to Clinical Trials 2Dompé Offers a New "Window" on the World of Scientific Research, with the http://www.dompetrials.com Website, Dedicated to Clinical Trials 3Integrated Clinical Trial Services and Clinical Trial Marketing Communications Form Joint Venture 2Integrated Clinical Trial Services and Clinical Trial Marketing Communications Form Joint Venture 3
... Regenicin , Inc. (OTC Bulletin Board: RGIN ) ... therapies to restore the health of damaged tissues and organs, ... 1st Annual LifeTech Investor Conference at the JW Marriott Marquis ... Regenicin,s core concept and business model for bringing regenerative medicine ...
... Trimega Laboratories is pleased to announce that it has been ... Investors in People (IIP) Standard. Its accreditation ... IIP and reflects the commitment and hard work undertaken by ... achievement is that, as a substance abuse testing ...
Cached Medicine Technology:Regenicin CEO to Speak at LifeTech Investor Conference in Miami, Florida November 12th, 2010 2IIP Recognition for Substance Abuse Testing Lab Trimega Laboratories 2
... Field (PEMF) bone growth stimulation delivered by ... long bone and small bone nonunions. Physio-Stim ... brace, or clothing without lessening its effectiveness. ... compact, lightweight unit including success rates as ...
Our products, with carefully researched design features, are tailored to making arthroscopic and ligament reconstructive surgery more reproducible, easier, quicker and safer....
... Screws. Optimal screw design ... selection options. Robust threads ... and chamfered screw hub ... tissue fixation. Features a ...
Cannulated Interference Screws...
Medicine Products: