Navigation Links
U.S. Food And Drug Administration (FDA) Grants Traditional Approval for INTELENCE(R) (etravirine)
Date:11/25/2009

BRIDGEWATER, N.J., Nov. 25 /PRNewswire/ -- The FDA granted traditional approval for INTELENCE® (etravirine) tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI). INTELENCE is the only NNRTI specifically indicated for use in treatment-experienced adults who are experiencing virologic failure with HIV-1 strains resistant to an NNRTI and other antiretroviral (ARV) agents. The traditional approval is based on 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.

"With its efficacy and tolerability demonstrated in 48-week studies, etravirine (INTELENCE) has become an important option for many treatment-experienced patients with resistance to NNRTIs or other antiretrovirals," said DUET clinical investigator Charles Hicks, MD, associate professor of medicine at Duke University's Division of Infectious Diseases in Durham, North Carolina.

INTELENCE received accelerated approval by the FDA in January 2008 and has been approved in more than 50 countries since then. In January 2009, an application for traditional approval was submitted to the FDA, which included 48-week data from DUET-1 and DUET-2.

INTELENCE, in combination with other antiretroviral agents, is 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 an NNRTI and other antiretroviral (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 antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults.

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

  • Treatment his
    '/>"/>

Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Shire Announces Publication of Open-Label Study on Coadministration of INTUNIV(TM) (guanfacine) Extended-Release Tablets with Stimulants
2. Euro RSCG Life Presents Proprietary Survey Insights at Food and Drug Administration Hearing on Pharmaceutical Promotion via Online and Social Media
3. United States Patent Office Issues Patent Covering the Approved Administration of Kuvan With Food
4. U.S. Food and Drug Administration Clears Alcatel-Lucent Remote Patient Monitoring Solution for Sale in the United States
5. Caliper Life Sciences Presents LabChip(R) Platform to the U.S. Food and Drug Administration
6. Oramed Pharmaceuticals was Chosen to Present Results of a GLP-1 Analog Oral Administration Study at the Diabetes Technology Societys Ninth Annual Meeting (November 5-7, 2009; San Francisco, CA)
7. U.S. Food and Drug Administration Approves CRESTOR(R) for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia
8. Food and Drug Administration Expert to Deliver Keynote Address
9. Chinese Food and Drug Administration Approves Gabexate Mesylate as Pharmaceutical Raw Material
10. Biostar Pharmaceuticals, Inc. Receives the Chinese Military Drug Administration Clearance to Begin Clinical Trial for Zushima Analgesic Aerosol Spray
11. United States Patent Office Allows Claims Covering the Approved Administration of Kuvan with Food
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... 2014 According to market ... Mobile, Industrial, & Laboratory), Industry (Food, Pharmaceutical, Biotechnology, ... Rotary) & Geography - Global Trends & Forecast ... the lyophilization market on the basis of various ... of the market size of each of these ...
(Date:9/19/2014)... 19, 2014  Lpath, Inc. (NASDAQ: ... therapeutics, announced today that it has entered into ... common stock and 3,605,042 unregistered warrants in a ... one registered share of common stock and one ... common stock will be $3.475.  The warrants have ...
(Date:9/19/2014)... LONDON , September 19, 2014 ... hat Pharma IQ den äußerst erfolgreichen Serialisierungs-Countdown-Kalender aktualisiert, ... abdeckt. Die interaktive PDF, verfügbar unter pharmaserialisation.com ... an dem sie jeweils in Kraft treten. ... der Serialisierung nicht länger um das "ob", sondern ...
Breaking Medicine Technology:Lyophilization Market Worth $5,121.5 Million by 2019 2Lyophilization Market Worth $5,121.5 Million by 2019 3Lpath, Inc. Announces $12.5 Million Registered Direct Offering 2Lpath, Inc. Announces $12.5 Million Registered Direct Offering 3Pharma IQ stellt weltweite Serialisierungsfristen in seinen Countdown-Kalender 2014 - 2018 2
(Date:9/19/2014)... 2014 Unbound , an international humanitarian ... regions of the Philippines being affected by both a tropical ... families evacuated to the nearest public schools while others moved ... and gusty winds to portions of the northern Philippines. ... homes filled with more than 10 feet of water. ...
(Date:9/19/2014)... Phoenix, AZ (PRWEB) September 19, 2014 Hastings ... over 30 years in the industry, announces a record number ... firm handles a wide variety of serious injury cases as ... cases along with dog bite related accident cases and others. ... Hastings and Hastings has stood the test of time when ...
(Date:9/19/2014)... U.S. military troops deployed to sunny climates may have ... new study. Many returning troops reported getting ... military personnel developed blisters on their skin or noticed ... their moles since being deployed overseas. All of ... the study authors noted. "The past decade of ...
(Date:9/19/2014)... Alan Mozes HealthDay Reporter ... Cancer patients burdened by stress and family conflicts before ... their operation, a new study suggests. Investigators found ... have a nearly three times greater risk for complications ... of life. "We,ve long known that patient quality ...
(Date:9/19/2014)... Pittsburgh, PA (PRWEB) September 19, 2014 ... I fear getting wrinkles due to stretching the skin ... from Anniston, Ala. "This inspired me to design a ... HANDS-FREE EYE CONTACT LENS SYSTEM provides a quicker, easier, ... eliminates the need to perform this task manually, saves ...
Breaking Medicine News(10 mins):Health News:Double Threat in Philippines Displaces Thousands of Unbound Families 2Health News:Hastings And Hastings Announces a Record Number of Visitors to Its New Phoenix Personal Injury Website 2Health News:Some U.S. Troops May Face Greater Skin Cancer Risk 2Health News:Family Squabbles Can Derail Recovery From Cancer Surgery 2Health News:Family Squabbles Can Derail Recovery From Cancer Surgery 3
... , WASHINGTON, June 23 Today the 400,000-strong ... Manufacturers of America (PhRMA) for its commitment to ... 50 percent for seniors who fall into the ... Phillips, RetireSafe President, called the commitment, "a huge ...
... disorders are frequently seen as psychological or societal,diseases, but ... study,shows that the levels of a brain protein differ ... and occasionally fatal eating disorder most commonly,affecting women. Scientists ... some studies suggest a link to low levels of ...
... Derma Sciences, Inc. (OTC Bulletin Board: ... today that it has begun shipping BIOGUARD(TM) Barrier Dressings ... has been awarded reimbursement codes for the dressings, allowing ... will offer surgeons, wound care clinicians, infection control experts ...
... Pa., June 23 The Department of Health has received ... Housing and Urban Development, or HUD, to implement a new ... in Erie and Philadelphia. , , "The Healthy ... housing related hazards for children such as mold, radon, and ...
... ... Vivacare has included medication rebate coupons and medication brochures as ... the needs of physicians and patients, and improve medication adherence. 69% ... help them to fill their medication at the pharmacy. 86% of ...
... /PRNewswire-Asia/ -- Wan (Corporate Services) Ltd., the,sole agent of Perrier in Hong ... Perrier. , Perrier Clarifies ... We strongly believe the Consumer Council Findings is not correct. , ... Nitrite in Perrier is,not correct. , Nitrite content ...
Cached Medicine News:Health News:Derma Sciences Announces First Commercial Sales of BIOGUARD(TM) Barrier Dressings 2Health News:Derma Sciences Announces First Commercial Sales of BIOGUARD(TM) Barrier Dressings 3Health News:Derma Sciences Announces First Commercial Sales of BIOGUARD(TM) Barrier Dressings 4Health News:Pennsylvania Department of Health Receives Recovery Funds for New Healthy Homes Program 2Health News:Vivacare Patient Education Service Includes Medication Rebates and Brochures to Improve Medication Adherence 2Health News:Vivacare Patient Education Service Includes Medication Rebates and Brochures to Improve Medication Adherence 3Health News:Perrier Clarifies the NITRITE Level in Consumer Council Findings 2
Hard protective shields for post-operative or post-injury use. Universal, or Left/Right specific. Packaged 12 per box....
Hard protective shields for post-operative or post-injury use. Universal, or Left/Right specific. Packaged 12 per box....
... provide a broad selection of ... a wide variety of ophthalmic ... is packaged sterile, complete with ... switch in the "off " ...
... provide a broad selection of ... a wide variety of ophthalmic ... is packaged sterile, complete with ... switch in the "off " ...
Medicine Products: