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

lished in pediatric patients or in treatment-naive adult patients.

DUET-1 AND DUET-2

The traditional approval filing includes the 48-week efficacy and safety results of DUET-1 and DUET-2, two Phase 3 randomized, placebo-controlled studies that examined the use of INTELENCE in combination with other antiretroviral agents in adult treatment-experienced HIV-1 patients with documented resistance to NNRTIs and protease inhibitors. Participants in the DUET studies were randomized to receive INTELENCE 200 mg twice daily or placebo, each given in addition to a background regimen. For all patients, the BR included darunavir/ritonavir, plus at least two investigator-selected antiretroviral drugs (N(t)RTIs with or without enfuvirtide). Forty-eight-week data from this study were presented at the 15th Conference on Retroviruses and Opportunistic Infections in Boston on February 7, 2008.

Important Safety Information

INTELENCE does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

  • Severe and potentially life-threatening skin reactions, including Stevens-Johnson Syndrome, hypersensitivity reaction, and erythema multiforme, have occurred (<0.1 percent) in patients taking INTELENCE. Treatment with INTELENCE should be discontinued and appropriate therapy initiated if severe rash develops.
  • In general, in clinical trials, rash was mild to moderate, occurred primarily in the second week of therapy, and was infrequent after Week 4. Rash generally resolved within 1-2 weeks on continued therapy. Discontinuation rate due to rash was two percent.
  • Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral (ARV) therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established.
  • Immune reconstit
    '/>"/>

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:9/2/2014)... Two Kansas State University biochemists have discovered a ... for Staphylococcus aureus , a pathogenic bacterium that ... year. , Brian Geisbrecht, professor of biochemistry and molecular ... S. aureus , which is the cause of ... scientific journal Proceedings of the National Academy of ...
(Date:9/2/2014)... -- Many people believe that marijuana is not addictive, ... more people are able to obtain and consume cannabis ... people are less likely to perceive it as addictive ... Massachusetts General Hospital,s Center for Addiction Medicine, said in ... cannabis use can have significant consequences, and we know ...
(Date:9/2/2014)... Mass. (PRWEB) September 02, 2014 Healthcare ... latest and most complete oncology guidelines available at the ... Health and the National Comprehensive Cancer Network® ... with other evidence and guidelines in the content available ... , NCCN, a not-for-profit alliance of 25 of ...
(Date:9/2/2014)... that the key to more youthful immune function might ... published in the Journal of Leukocyte Biology ... of old mice had different responses to Mycobacterium ... changes were reversed by ibuprofen. , "Inflammation in old ... Joanne Turner, Ph.D., a researcher involved in the work ...
(Date:9/2/2014)... 02, 2014 Nanomedicine is essentially ... diagnosing, treating and/or prevention of diseases and infections. ... cardiovascular, neurological, and oncology diseases. , Nanomedicine ... to various nanoparticles, their medical usages, and their ... considerable scope for research in this domain, and ...
Breaking Medicine News(10 mins):Health News:Biochemists find new treatment options for staph infections, inflammatory diseases 2Health News:'Pot Addiction' May Be Real, Study Suggests 2Health News:DynaMed™ to Utilize Information from the National Comprehensive Cancer Network® 2Health News:DynaMed™ to Utilize Information from the National Comprehensive Cancer Network® 3Health News:DynaMed™ to Utilize Information from the National Comprehensive Cancer Network® 4Health News:Nanomedicine Market: An Overview of Growth Factors and Future Prospects by Transparency Market Research 2Health News:Nanomedicine Market: An Overview of Growth Factors and Future Prospects by Transparency Market Research 3
... we interviewed a doctor - Dr.Makani Hemadri, who has seen ... facing the doctor community at large objectively. Many doctors ... Apparently almost 25,000 doctors of Indian orgin serve the National ... countries as distant and remote as Fiji, Belize and Zambia ...
... have not lost faith, but we have transferred it from ... ,Healthcare in India is presently the cynosure of ... medical brains, is also recording excellence in healthcare services. ... India is on the road to being an important healthcare ...
... painful rashes. Prescription medications including steroid creams that ... ,When over five million Americans suffer from that ... frenzied response, especially when backed by some kind of ... even though experts are skeptical. ,"We can ...
... by University of Leeds researchers suggests that proteins that ... against Alzheimer's. ,In laboratory tests, the ... the brain prevented the accumulation of beta amyloid, the ... leader Professor Nigel Hooper says that the findings, published ...
... anthropologists have embarked on a project to save Tibetan folk ... Gerald Roche, the volunteer-run Tibetan Endangered Music Project (TEMP) aims ... return them back to the community. ,"The goal ... to our communities. We want to record as many songs ...
... a growing segment of the population but vote less ... favor Democrats over Republicans, said a study published Friday. ... older now account for 45.2 percent of the US ... Vote said in its study titled "Unmarried America 2007: ...
Cached Medicine News:Health News:Interview With a Surgeon Hidden Hero of the NHS 2Health News:Interview With a Surgeon Hidden Hero of the NHS 3Health News:Interview With a Surgeon Hidden Hero of the NHS 4Health News:Interview With a Surgeon Hidden Hero of the NHS 5Health News:Interview With a Surgeon Hidden Hero of the NHS 6Health News:Interview With a Surgeon Hidden Hero of the NHS 7Health News:Interview With a Surgeon Hidden Hero of the NHS 8Health News:Lets Care For Our Physicians A Salute to Them on Doctors Day! 2Health News:Lets Care For Our Physicians A Salute to Them on Doctors Day! 3Health News:Experts Critical of a New OTC Product to Treat Psoriasis 2Health News:Experts Critical of a New OTC Product to Treat Psoriasis 3Health News:Proteins Behind Mad Cow Disease may Protect Against Alzheimer's 2Health News:Digital Music Project Aims to Save Tibetan Folk Songs from Extinction 2Health News:Single Americans Vote Less, but Lean Towards Democrats: Study 2
(Date:9/2/2014)... SANTA CLARA, Calif. , Sept. 2, 2014 /PRNewswire/ ... , is now offering a special promotion for Invisalign. ... instead of brackets and wires. It is often the ... who prefer the convenience and aesthetics of it. For ... $3,900, which is a significant savings from the usual ...
(Date:9/2/2014)... September 2, 2014 , ... 2014 provide insight into treatment and outcomes of ... practice --   Data from nearly ... in the FIELD-Atrial Fibrillation (GARFIELD-AF), an innovative, independent ... strategies for atrial fibrillation (AF) patients remain sub-optimal ...
(Date:9/2/2014)... , Sept. 2, 2014 /PRNewswire-iReach/ -- Ortho Development® ... Alpine™ Hip Stem, the latest addition to its ... Stem is intended for use in total hip ... http://photos.prnewswire.com/prnh/20140830/141676 Alpine was ... stem philosophy. ODEV,s engineers worked closely with a ...
Breaking Medicine Technology:Santa Clara Cosmetic Dentist, Dr. Alan Frame, is Now Offering a Special on Invisalign 2Data From Global Atrial Fibrillation Registry Show Antithrombotic Agents Not Optimally Used to Prevent Stroke 2Data From Global Atrial Fibrillation Registry Show Antithrombotic Agents Not Optimally Used to Prevent Stroke 3Data From Global Atrial Fibrillation Registry Show Antithrombotic Agents Not Optimally Used to Prevent Stroke 4Data From Global Atrial Fibrillation Registry Show Antithrombotic Agents Not Optimally Used to Prevent Stroke 5Data From Global Atrial Fibrillation Registry Show Antithrombotic Agents Not Optimally Used to Prevent Stroke 6Data From Global Atrial Fibrillation Registry Show Antithrombotic Agents Not Optimally Used to Prevent Stroke 7Data From Global Atrial Fibrillation Registry Show Antithrombotic Agents Not Optimally Used to Prevent Stroke 8Data From Global Atrial Fibrillation Registry Show Antithrombotic Agents Not Optimally Used to Prevent Stroke 9Ortho Development Receives FDA Clearance for Alpine Hip Stem 2
A wide selection of bipolar forceps and hemostatic erasers to facilitate most ophthalmic surgical procedures....
Mendez Multi-Purpose LASIK Forceps. To enter, dissect, elevate and smooth the flap. Combined features of Spatula, Dissector and Forceps, Titanium...
To enter, dissect, elevate and smooth the flap. Combined features of Spatula, Dissector and Forceps. - Also available in Titanium...
Khosla Precision and Quality in Medical and Surgical Products....
Medicine Products: