Navigation Links
FDA Approves New Dosage Strength for INTELENCE®
Date:1/3/2011

TITUSVILLE, N.J., Jan. 3, 2011 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved a label update to include a 200 mg formulation of INTELENCE® (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adults with resistance to an NNRTI and other antiretroviral (ARV) agents.  

The recommended oral dose of INTELENCE tablets is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal. The new 200 mg product formulation is expected to launch in the U.S. later this month, and the 100 mg tablet will remain available. Patients who are unable to swallow INTELENCE tablets whole may disperse the tablets in a glass of water.

The FDA granted accelerated approval to INTELENCE in January 2008, and it has since been approved in more than 65 countries. INTELENCE received traditional FDA approval in November 2009, based on 48-week data from the DUET-1 and DUET-2 studies, and is currently marketed in the U.S. by Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P.

INTELENCE IndicationINTELENCE, in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in ARV treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other ARV agents. This indication is based on Week 48 analyses from two randomized, double-blind, placebo-controlled trials of INTELENCE. Both studies were conducted in clinically advanced, three-class ARV (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 ARV agents with INTELENCE is associated with an increased likelihood of treat
    '/>"/>

  • SOURCE Tibotec Therapeutics
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5

    Related medicine technology :

    1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
    2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
    3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
    4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
    5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
    6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
    7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
    8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
    9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
    10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
    11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:7/10/2014)... , July 10, 2014  Decision Resources ... surveyed infectious disease (ID) specialists are willing to ... Orbactiv (oritavancin) for use as OPAT, approximately two-thirds ... these agents to their hospital inpatients. However, our ... OPAT patients are initiated on OPAT following hospital ...
    (Date:1/15/2014)... , Jan. 15, 2014 Sono-Tek Corporation (OTC BB: ... ended November 30, 2013, compared to sales of $2,202,000 for ... Once again, this quarter has also shown growth over the ... first quarter of this fiscal year. Markets that experienced sales ...
    (Date:1/15/2014)... GRAND RAPIDS, Mich. , Jan. 15, 2014 As ... of the flu virus, select Meijer pharmacies in ... and strep throat to eligible patients, enabling Meijer pharmacists to ... under strict protocol set by a physician participating in the ...
    Breaking Medicine Technology:Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 2Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 3Sono-Tek Announces Third Quarter Results 2Sono-Tek Announces Third Quarter Results 3Sono-Tek Announces Third Quarter Results 4Meijer Pharmacy Offers Free Flu, Strep Testing as Influenza Cases Rise Across the Midwest 2Meijer Pharmacy Offers Free Flu, Strep Testing as Influenza Cases Rise Across the Midwest 3
    ... ATLANTA, Oct. 13, 2011 Anesthesiologists are quickly turning ... cost-effective, high quality care.  An annual survey of anesthesia ... of survey respondents indicating that IT solutions are a ... key driver in IT decisions.  The survey of 212 ...
    ... 13, 2011 Cumberland Pharmaceuticals Inc. ... release third quarter 2011 financial results after the market closes ... Internet webcast will be held on Thursday, November 3, 2011, ... To participate in the call, please dial 877-303-1298 (for ...
    Cached Medicine Technology:Annual Survey Demonstrates Increased Demand for Anesthesia Information Management Systems 2Annual Survey Demonstrates Increased Demand for Anesthesia Information Management Systems 3
    (Date:7/12/2014)... Floor-grade instrument buyers ... of 5. This above-average score represents favorable conditions ... negotiation power over the three years to 2014. ... the period, surging demand for healthcare services and ... product development, have placed upward pressure on the ...
    (Date:7/11/2014)... 2014 Recently, MagicQuinceaneraDresses.com, the popular online ... collection of 2014 Quinceanera dresses . The company’s ... to look fashionable without paying a large amount of ... to 57% off. , The company’s online shop has ... amazing special occasion outfits. In addition to exquisite Quinceanera ...
    (Date:7/11/2014)... Ticket Down reports that tickets to the ... place World Cup Match between Brazil and Netherlands ... place on Saturday, July 12th at Estadio Nacional de Brasilia ... take place on Sunday, July 13th at Estadio Jornalista Mario ... for the 2014 World Cup are guaranteed to be authentic ...
    (Date:7/11/2014)... FRIDAY, July 11, 2014 (HealthDay News) -- People with the ... condition called peripheral artery disease (PAD), a new study suggests. ... supply blood to the limbs, most often the legs. The ... narrowing of the arteries throughout the body. People with PAD ... Researchers analyzed data from nearly 6,800 people with PAD who ...
    (Date:7/11/2014)... As part of its morcellator ... has been closely monitoring the ongoing meeting of ... Obstetrics and Gynecology Devices Panel, which has been ... risks associated with the use of power morcellators ... report published by Dow Jones Business News, a ...
    Breaking Medicine News(10 mins):Health News:Floor-Grade Instruments Procurement Category Market Research Report from IBISWorld has Been Updated 2Health News:Floor-Grade Instruments Procurement Category Market Research Report from IBISWorld has Been Updated 3Health News:Floor-Grade Instruments Procurement Category Market Research Report from IBISWorld has Been Updated 4Health News:Cheap Quinceanera Dresses Now Available At MagicQuinceaneraDresses.com 2Health News:Argentina vs. Germany World Cup Finals Tickets & Brazil vs. Netherlands 3rd Place World Cup Tickets Are in Huge Demand 2Health News:Poor More Prone to Leg Circulation Trouble 2Health News:Morcellator Lawsuit News: Bernstein Liebhard LLP Notes Financial Ties Between FDA Advisory Panel Members and Manufacturers of Power Morcellators 2Health News:Morcellator Lawsuit News: Bernstein Liebhard LLP Notes Financial Ties Between FDA Advisory Panel Members and Manufacturers of Power Morcellators 3Health News:Morcellator Lawsuit News: Bernstein Liebhard LLP Notes Financial Ties Between FDA Advisory Panel Members and Manufacturers of Power Morcellators 4
    ... Surgical Company (Nasdaq: STAA ), a developer, manufacturer ... announced the completion of a registered direct offering of 4,255,319 ... per share, which was the closing market price on June ... million because the Company did not use an underwriter for ...
    ... & rescue manager won contest to clone beloved pet Trakr, hero ... Can you clone a hero? ... rescue dog and 9-11 hero, Trakr, will receive five answers to ... California biotech company that is offering the first commercial dog cloning ...
    ... ... that it is taking sign-ups for this year,s annual subtle energies and healing conference. ... is called "Sacred Synthesis: Science with Heart". , ... Denver, CO (PRWEB) June 17, 2009 -- ISSSEEM (International ...
    ... ... of the clinical study that was performed using the Bariatric Advantage High Protein Meal ... Obesity (ECO). , ... Amsterdam, Holland (Vocus) June 17, 2009 -- Bariatric Advantage presented the results of the ...
    ... ... Remote Control 4.0. It allows help desk staff to administer and remotely control ... easy to find computers With its unique search engine. It can find the ... http://www.intelliadmin.com/blog/index.php/2009/06/remote-control-40-beta-rc4-and-usb-disabler-pro/ , ...
    ... ... of the University of Oklahoma, OU Physicians has established a standard of efficient patient centered ... facility was designed to consolidate the private practices for physicians teaching at the University of ... ...
    Cached Medicine News:Health News:STAAR Surgical Completes Common Stock Offering 2Health News:STAAR Surgical Completes Common Stock Offering 3Health News:BioArts International Clones 9-11 Hero Dog - Owner to Receive Five Cloned Puppies June 17 in Los Angeles 2Health News:BioArts International Clones 9-11 Hero Dog - Owner to Receive Five Cloned Puppies June 17 in Los Angeles 3Health News:2009 ISSSEEM Conference to Have Deepak Chopra Discuss Bridging Science and Spirit 2Health News:2009 ISSSEEM Conference to Have Deepak Chopra Discuss Bridging Science and Spirit 3Health News:Bariatric Advantage High Protein Meal Replacement Clinical Study Presented at European Congress on Obesity 2Health News:Windows 7 Compatible Remote Desktop Software Released (Beta 4) 2
    EC+ Extra Care Bariatric Bed...
    ... system is a unique healthcare ... dual width capability with a ... design. Specifically developed to accommodate ... the easy-to-use Tri-Flex I system ...
    ... Nebulizer W/ 7` CR Resistant Oxygen Tubing., ... treatment times , ,Provide fine particles ... respirable particles) than conventional nebulizers, ,Our ... deliver fast and effective treatment more efficiently ...
    ... Nebulizer Disposable Prefilled 28%-100% FIO 2 1000ML ... ,Our prefilled nebulizers provide unmatched performance and ... cool high-output aerosols adjustable from 28% to 100% ... of solutions: sterile water for inhalation, USP; 0.45% ...
    Medicine Products: