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

0

GOOD

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:12/4/2009)PEMBROKE, Bermuda, Dec. 4 Allied World Assurance,Company Holdings, Ltd (NYSE: AWH ) today announced that Scott Carmilani,President and Chief Executive Officer, and Jack Sennott, Executive Vice,Pres
(Date:12/4/2009)MADISON HEIGHTS, Mich., Dec. 4 The Editorial Advisory and Securities Review Committee of BetterInvesting Magazine today announced Allergan, Inc. (NYSE: AGN ) as its February 2010 "Stock to Stud
(Date:12/4/2009)Late recurrence is a risk for some pediatric cancers, particularly Ewing sarcomas and tumors of the central nervous system, according to a new study published online December 4 in the Journal of the
(Date:12/4/2009)More than 15 million Americans are recruited annually to participate in clinical trials according to the Alliance for Human Research Protection (AHRP), and most will be compensated for their participa
(Date:12/4/2009)Increasing exercise, water and fruit consumption leads to success, study finds , , FRIDAY, Dec. 4 (HealthDay News) -- Increased exercise, reduced soda consumption and self-weighing are among
Breaking Medicine News(10 mins):Health News:Allied World to Present at the 2009 Goldman Sachs U.S. Financial Services Conference 2Health News:BetterInvesting Magazine Releases February Stock to Study and Undervalued Stock Choicesfor Investors' Informational and Educational Use 2Health News:Human guinea pigs wary of high-paying medical trials 2Health News:Teens Lose More Weight Using Healthy Strategies 2
...l Will Retain Decision Resources, Clinical Gold St... a New Report from Decision Resources , , WALTHAM...world,s leading research and advisory firms for ph...e attribute that most influences their prescribing...
...ws those who respond to lapatinib survive longer, ...he drug lapatinib could be used to treat aggressiv... of a phase 2 study. , Inflammatory breast cancer...apid onset of swelling, redness of breast skin, a ...
...ds they test higher than unmedicated peers in grad...ews) -- Children who take medication to treat atte...ter in elementary school than those who don,t, a n...h tests and 5.4 points higher on reading tests tha...
...nt Clinton supports global tribute to inspire peop...l 27 46664 and the Nelson Mandela Foundation are ...creation of an official Mandela Day , to be held ...heir individual power to make an imprint and help ...
...TON, April 27 A study of child development and un...SA is the first to link age-appropriate safety t...en,s cognitive, behavioral and physical developmen... parents how to keep their kids safe, but this rep...
...ly invasive varicose vein treatment market is larg...rch Group , , WALTHAM, Mass., April 27 According...ties in Brazil : Varicose Vein Treatment Devi...tment device market in the country, widely conside...
Other Medicine News:Health News:For Bipolar Depression, Surveyed Experts Indicate That Current and Emerging Therapies Have No Advantage Over Seroquel in Decreasing the Severity of Symptoms 2Health News:For Bipolar Depression, Surveyed Experts Indicate That Current and Emerging Therapies Have No Advantage Over Seroquel in Decreasing the Severity of Symptoms 3Health News:Drug May Help Against Inflammatory Breast Cancer 2Health News:Meds Help Kids With ADHD in Classroom 2Health News:Meds Help Kids With ADHD in Classroom 3Health News:46664 and the Nelson Mandela Foundation Call for Establishment of Global 'Mandela Day' 2Health News:46664 and the Nelson Mandela Foundation Call for Establishment of Global 'Mandela Day' 3Health News:46664 and the Nelson Mandela Foundation Call for Establishment of Global 'Mandela Day' 4Health News:46664 and the Nelson Mandela Foundation Call for Establishment of Global 'Mandela Day' 5Health News:Connecting the Dots: For the First Time a Safety Report Links Research on a Child's Development and the Risk of Unintentional Injury With Age-Appropriate Safety Recommendations 2Health News:Connecting the Dots: For the First Time a Safety Report Links Research on a Child's Development and the Risk of Unintentional Injury With Age-Appropriate Safety Recommendations 3Health News:Connecting the Dots: For the First Time a Safety Report Links Research on a Child's Development and the Risk of Unintentional Injury With Age-Appropriate Safety Recommendations 4Health News:Connecting the Dots: For the First Time a Safety Report Links Research on a Child's Development and the Risk of Unintentional Injury With Age-Appropriate Safety Recommendations 5Health News:Growth Opportunity in Brazil's Varicose Vein Treatment Device Market 2Health News:Growth Opportunity in Brazil's Varicose Vein Treatment Device Market 3
(Date:12/4/2009)Workers Ensure Emergency Deliveries are Transported ,, PHILADELPHIA, Dec. 4 Teamster members employed by the Philadelphia chapter of the American Red Cross are hard at work educating the public abo
(Date:12/4/2009)SALT LAKE CITY, Dec. 4 Dynatronics Corporation (Nasdaq: DYNT ) announced it has signed a sole-source vendor agreement to provide therapy equipment and rehab supplies to Benchmark Physical Therapy wi
(Date:12/4/2009)LAKE FOREST, Ill., Dec. 4 Hospira, Inc. (NYSE: HSP ), a leading global specialty pharmaceutical and medication delivery company, today announced the launch of its next-generation 50 mL and 100 mL V
Breaking Medicine Technology:Striking Red Cross Workers Raise Public Awareness of Unsafe Working Conditions 2Hospira Expands VisIV(TM) Portfolio to Offer Complete Range of Environmentally Friendly I.V. Containers 2Hospira Expands VisIV(TM) Portfolio to Offer Complete Range of Environmentally Friendly I.V. Containers 3Hospira Expands VisIV(TM) Portfolio to Offer Complete Range of Environmentally Friendly I.V. Containers 4Idenix Announces Data Presentations at the 60th Annual Meeting of the American Association for the Study of Liver Diseases 28AASLD 29 14321 1Idenix Announces Data Presentations at the 60th Annual Meeting of the American Association for the Study of Liver Diseases 28AASLD 29 14321 2Idenix Announces Data Presentations at the 60th Annual Meeting of the American Association for the Study of Liver Diseases 28AASLD 29 14321 3URAC Introduces New Performance Measures and Reporting Standards for Pharmacy Benefit Management and Drug Therapy Management Accreditation 5171 1URAC Introduces New Performance Measures and Reporting Standards for Pharmacy Benefit Management and Drug Therapy Management Accreditation 5171 2URAC Introduces New Performance Measures and Reporting Standards for Pharmacy Benefit Management and Drug Therapy Management Accreditation 5171 3URAC Introduces New Performance Measures and Reporting Standards for Pharmacy Benefit Management and Drug Therapy Management Accreditation 5171 4PDL BioPharma Completes October 1 Special Dividend Payment 5167 1
...France, Sept. 11 NicOx S.A.,(Eurolist: COX) today...sclosed promising top-line results from its first ...l entity licensed from NicOx which is a novel,resp... good safety and,tolerability profile, in addition...be beneficial in TOPIGEN,s target indication of Ch...
...1 S*BIO Pte Ltd today announced the,development o...ound,SB1518, for the treatment of myeloproliferati...nancies. MPD is believed to be caused by a specifi...d group of hematological,malignancies in which the...D is characterised by an excess of blood cells and...
Other Medicine Technology:NicOx Reports TOPIGEN to Advance TPI-1020 Into Phase 2 for COPD Following Promising Clinical Results 2NicOx Reports TOPIGEN to Advance TPI-1020 Into Phase 2 for COPD Following Promising Clinical Results 3NicOx Reports TOPIGEN to Advance TPI-1020 Into Phase 2 for COPD Following Promising Clinical Results 4NicOx Reports TOPIGEN to Advance TPI-1020 Into Phase 2 for COPD Following Promising Clinical Results 5S*BIO to Develop New JAK-2 Inhibitor for Treatment of Myeloproliferative Disorders and Hematological Malignancies 2
...icare's Prep Pads offer convenience, low cost, eas...applications. Each package is terminally sterilize...tient. Sterile Skin Protectant Prep Pads prepare t...dage. When dry, it leaves a thin film on the skin'...
IV Prep Swab Sticks
Triad Plus BZK Swabsticks
...ad Plus PVP-I Prep Swabsticks are saturated with a...to 1% available iodine. Povidone Iodine is vir...branes. It is also non-staining to the skin or nat...s on contact; they are sturdy tools for removing s...
Medicine Products: