Navigation Links
Tibotec Submits Application to U.S. Food and Drug Administration Seeking Traditional Approval for INTELENCE(TM) (etravirine)
Date:2/5/2009

BRIDGEWATER, N.J., Feb. 5 /PRNewswire/ -- Tibotec, Inc. today announced it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking traditional approval for INTELENCE(TM) (etravirine) tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI). The application for traditional approval includes 48-week data from two Phase 3 studies known as DUET-1 and DUET-2. INTELENCE is currently marketed in the U.S. by Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P.

INTELENCE received accelerated approval in January 2008. As part of the post-marketing commitment, Tibotec is required to submit 48-week data from the DUET studies to the FDA in order for it to consider traditional approval for INTELENCE.

INTELENCE, in combination with other antiretroviral agents, is currently indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a NNRTI and other antiretroviral (ARV) agents.

This indication is based on Week 24 analyses from two randomized, double-blind, placebo-controlled trials of INTELENCE. Both studies were conducted in clinically advanced, three-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults.

The following points should be considered when initiating therapy with INTELENCE:

  • Treatment history and, when available, resistance testing, should guide the use of INTELENCE.
  • The use of other active antiretroviral agents with INTELENCE is associated with an increased likelihood of treatment response.
  • In patients who have experienced virologic failure on a NNRTI-containing regimen, do not use INTELENCE in combination with only N[t]RTIs.
  • The risks and benefits of INTELENCE have not been estab
    '/>"/>

SOURCE Tibotec, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine news :

1. Tibotec and Emcure Collaborate on Access to Darunavir for India
2. Tibotec presents interim findings for TMC435, an investigational genotype 1 hepatitis C treatment
3. Tibotec Pharmaceuticals a Respectful Partner to HIV Community in Pricing of Novel New HIV NNRTI, INTELENCE
4. Interleukin Genetics Submits Plan to Regain Compliance with Continued Listing Standards
5. STERIS Corporation Submits New Sterilization System To FDA and Announces Developments on SYSTEM 1 Warning Letter
6. TriServ Alliance Submits Final Bid for TRICARE South Region Contract
7. WorldHeart Submits IDE Application for a Pivotal Bridge-to-Transplant Study of the Levacor(TM) VAD
8. Biopure Submits IND Application for Proposed Clinical Trial in Patients with Acute Myeloid Leukemia
9. ViroPharma Submits Supplemental Biologics License Application for Cinryze(TM) to Treat Acute Attacks of Hereditary Angioedema
10. SCOLR Pharma, Inc. Submits Abbreviated New Drug Application for a 12-hour CDT-based Pseudoephedrine Formulation
11. TriServ Alliance Submits Bid for TRICARE South Region Contract
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2014)... 2014) Doctors who treat patients with a ... can face an agonizing treatment decision. , The ... and help relieve shortness of breath. But some ... can cause potentially fatal complications following transplantation. , ... Dilling, medical director of Loyola University Medical Center,s ...
(Date:4/17/2014)... University School of Medicine (BUSM) have discovered that ... an experimental model. The findings, reported in the ... , may lead to more effective treatments for ... of the leading causes of illness and death ... impact by limiting the productivity of workers and ...
(Date:4/17/2014)... 2014) Population Council scientists and their partners have found ... can prevent the transmission of multiple sexually transmitted infections ... HIV, herpes simplex virus 2 (HSV-2), and human papillomavirus ... that the gel is effective against multiple strains of ... vagina against all three viruses of at least eight ...
(Date:4/17/2014)... A new study has found that India,s shocking rates ... debt-ridden farmers who are clinging to tiny smallholdings ... ,cash crops, such as cotton and coffee, that are ... supports a range of previous case studies that point ... sector following the ,liberalisation, of the nation,s economy during ...
(Date:4/17/2014)... for more research to be carried out into ... Africa. In a paper in The Lancet ... with colleagues in the department of Parasitology and ... Ohio, University of Cambridge and the Royal Veterinary ... burden of HIV/AIDS and schistosomiasis of children, and ...
Breaking Medicine News(10 mins):Health News:Patients with rare lung disease face agonizing treatment dilemma 2Health News:Patients with rare lung disease face agonizing treatment dilemma 3Health News:BUSM researchers find anti-seizure drug may reduce alcohol consumption 2Health News:Animal study provides first evidence that gel can prevent multiple virus transmission in vagina/rectum 2Health News:New evidence of suicide epidemic among India's 'marginalized' farmers 2Health News:New evidence of suicide epidemic among India's 'marginalized' farmers 3Health News:More research called for into HIV and schistosomiasis coinfection in African children 2
... a new vaccine against childhood pneumonia, meningitis and ear ... Meanwhile, doctors are directing the supplies they do have ... such as those with sickle cell anemia, the AIDS ... ,PREVNAR fights the bacterium streptococcus pneumoniae, the leading ...
... in France, despite a diet rich in butter and other ... red wine, another staple of the French diet. //Scientists say ... explanation is pigments known as polyphenols. ,Polyphenols ... of the arteries. Polyphenols in red wine decreases the amount ...
... to a new study, there is no significant difference ... serotonin reuptake inhibitors (SSRIs) are now very widely used ... a brain chemical called serotonin that plays an important ... how individual SSRIs compare with one another. However, a ...
... A team of UK scientists has found six genes which ... that eventually, doctors will be able to gauge an individual ... genetic makeup.Only a small proportion of breast cancer cases are ... ,Two genes have already been firmly linked with some ...
... a new study alcoholics are prone to a kind of ... the study of alcohol on the health of aged people ... of persistent problem drinking were 20 per cent more likely ... Heavy drinkers ran a 10 per cent greater risk. These ...
... it thins the blood and prevents the clots that ... class of pain relievers known as nonsteroidal anti-inflammatory drugs.// ... and pains. The popular pain reliever ibuprofen blocks the ... sounds a warning for people who take both medicines. ...
Cached Medicine News:
(Date:1/14/2014)... , Jan. 14, 2014 /PRNewswire-iReach/ -- Acumed,s new ... targeting guide with accompanying instrumentation to place and insert ... to the soft tissue (e.g. ligament) repair or reconstruction ... repair heals. (Photo: http://photos.prnewswire.com/prnh/20140114/MN45636 ) ...
(Date:1/14/2014)... , Jan. 14, 2014 NineSigma , ... hold its Innovation Leadership Summit , May 14-16, ... Cleveland Ohio . ... and organizations committed to breakthrough achievements through open innovation. ...
(Date:1/14/2014)... 14, 2014   Evidera , a leading provider of ... Center for Drug Evaluation and Research (CDER), U.S. Food ... guidance document for a patient-reported outcome (PRO) measure in ... Disease Tool [EXACT] for Measurement of Symptoms of Acute ...
Breaking Medicine Technology:Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 2Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 3Expect the Unexpected from Leading Global Innovators at NineSigma Leadership Summit, Sharing Winning Strategies to Advance Innovation 2Expect the Unexpected from Leading Global Innovators at NineSigma Leadership Summit, Sharing Winning Strategies to Advance Innovation 3Expect the Unexpected from Leading Global Innovators at NineSigma Leadership Summit, Sharing Winning Strategies to Advance Innovation 4Evidera Announces Release of FDA Draft Guidance on Use of the "EXACT" to Measure Symptoms of COPD Exacerbations 2Evidera Announces Release of FDA Draft Guidance on Use of the "EXACT" to Measure Symptoms of COPD Exacerbations 3Evidera Announces Release of FDA Draft Guidance on Use of the "EXACT" to Measure Symptoms of COPD Exacerbations 4
... N.J., Feb. 1, 2012  Arena Pharmaceuticals, Inc. (NASDAQ: ... the US Food and Drug Administration (FDA) has notified ... meeting to discuss the lorcaserin New Drug Application (NDA) ... 2012. Confirmation and details of the meeting will be ...
... 2012 A new skin cancer drug tested for the ... Virginia G. Piper Cancer Center at Scottsdale Healthcare just received ... remarkable accomplishment in new drug development. (Photo: ... the first time in the world Jan. 23, 2007 in ...
Cached Medicine Technology:Arena Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Lorcaserin 2Arena Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Lorcaserin 3Arena Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Lorcaserin 4FDA Approves New Skin Cancer Drug First Tested in Arizona by Scottsdale Healthcare and TGen 2FDA Approves New Skin Cancer Drug First Tested in Arizona by Scottsdale Healthcare and TGen 3
Tennant straight tying forceps with extra delicate smooth jaws, 6 mm tying platform, For 9-0 to 11-0 sutures. Overall length 108 mm....
Catalano straight tying forcep has 6 mm V-grove tying platform. Overall length 100 mm....
McPherson straight tying forceps have straight shafts, tying platforms 4 mm, serrated handle, polished finish, overall length 85 mm....
Jayle tying forceps, straight....
Medicine Products: