Navigation Links
FDA Approves PREZISTA®/ritonavir Once-Daily Dosing for HIV-1 Treatment-Experienced Adults With No Darunavir Resistance-Associated Mutations
Date:12/13/2010

TITUSVILLE, N.J., Dec. 13, 2010 /PRNewswire/ -- Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., announced today that the U.S. Food and Drug Administration (FDA) has approved a revision to the dosing recommendation to include once-daily dosing of PREZISTA® (darunavir) tablets in combination with ritonavir for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adult patients with no darunavir resistance-associated mutations (DRV RAMs).(1)  

The revised dosing recommendation extends the same dosing already approved for treatment-naive patients – PREZISTA, co-administered with ritonavir (in combination with other antiretroviral agents and with food, once-daily (800/100 mg) – to treatment-experienced patients with no DRV RAMs. The previously approved dosing recommendation for PREZISTA/ritonavir in treatment-experienced patients (patients who have taken HIV medications in the past) was PREZISTA/ritonavir 600/100 mg twice daily.  

For antiretroviral treatment-experienced patients, genotypic testing is recommended. However, when genotypic testing is not feasible, PREZISTA/ritonavir 600/100 mg twice daily dosing is recommended.

The approval of this revision is based on 48-week data from the ODIN (Once-daily Darunavir In treatment-experieNced patients) study. ODIN evaluated the efficacy and safety of PREZISTA/ritonavir once daily vs. PREZISTA/ritonavir twice daily for the treatment of HIV-1 in treatment-experienced adult patients with no DRV RAMs (i.e., V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, or L89V).

"With this once-daily dosing recommendation, boosted PREZISTA is now a viable option for more treatment-experienced patients," said Glenn Mattes, president, Tibotec Therapeutics. "This approval reflects Tibotec's ongoing commitment to optimizing dosing strategies for HIV patients."  

Data from the Phase 3b
'/>"/>

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

Page: 1 2 3 4 5 6

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:4/24/2015)... 24, 2015 Hospira, Inc. (NYSE: ... of biosimilar therapies, spoke about the importance of extrapolation ... Generics Association (EGA) annual European Biosimilars Group conference in ... also announced the publication of a pivotal white paper ... full promise of biosimilars." Speaking at ...
(Date:4/24/2015)... Mass. , April 24, 2015  Blueprint ... BLU-554, a selective and potent inhibitor of fibroblast ... activity in models of hepatocellular carcinoma (HCC) that ... therapeutic candidate, BLU-554 induced complete tumor regression in ... an FGFR4-activating ligand at the highest dose levels. ...
(Date:4/23/2015)... IRVINE, Calif., April 23, 2015  Edwards Lifesciences Corporation (NYSE: ... of heart valves and hemodynamic monitoring, today reported net ... million, or $1.12 per diluted share.  Net income for ... or $0.56 per diluted share, and non-GAAP net income ... Net sales for the quarter ended March 31, 2015 ...
Breaking Medicine Technology:Hospira Leadership Presents at Preeminent European Biosimilars Forum, Announces New White Paper on Extrapolation 2Hospira Leadership Presents at Preeminent European Biosimilars Forum, Announces New White Paper on Extrapolation 3Hospira Leadership Presents at Preeminent European Biosimilars Forum, Announces New White Paper on Extrapolation 4Hospira Leadership Presents at Preeminent European Biosimilars Forum, Announces New White Paper on Extrapolation 5Hospira Leadership Presents at Preeminent European Biosimilars Forum, Announces New White Paper on Extrapolation 6Hospira Leadership Presents at Preeminent European Biosimilars Forum, Announces New White Paper on Extrapolation 7Blueprint Medicines Presents New Preclinical Data Demonstrating Its Drug Candidate BLU-554 Induces Significant Tumor Regression in Models of Hepatocellular Carcinoma 2Blueprint Medicines Presents New Preclinical Data Demonstrating Its Drug Candidate BLU-554 Induces Significant Tumor Regression in Models of Hepatocellular Carcinoma 3Edwards Lifesciences Reports First Quarter Results 2Edwards Lifesciences Reports First Quarter Results 3Edwards Lifesciences Reports First Quarter Results 4Edwards Lifesciences Reports First Quarter Results 5Edwards Lifesciences Reports First Quarter Results 6Edwards Lifesciences Reports First Quarter Results 7Edwards Lifesciences Reports First Quarter Results 8Edwards Lifesciences Reports First Quarter Results 9Edwards Lifesciences Reports First Quarter Results 10Edwards Lifesciences Reports First Quarter Results 11Edwards Lifesciences Reports First Quarter Results 12Edwards Lifesciences Reports First Quarter Results 13Edwards Lifesciences Reports First Quarter Results 14Edwards Lifesciences Reports First Quarter Results 15Edwards Lifesciences Reports First Quarter Results 16
...  Reportlinker.com announces that a new market ... catalogue: Triple Analysis: ... http://www.reportlinker.com/p0284888/Triple-Analysis-Apoptosis-Cancer-Vaccines-and-Antibodies.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication This ... development strategies by the two mechanism/target/effect ...
... Research Institute (IDRI) announces today that GlaxoSmithKline (GSK) Biologicals ... equipment that will assist IDRI as it designs and ... the developing world. IDRI will apply the gift as ... tuberculosis, leishmaniasis, malaria, leprosy, and pandemic influenza. ...
Cached Medicine Technology:Triple Analysis: Apoptosis, Cancer Vaccines and Antibodies 2Triple Analysis: Apoptosis, Cancer Vaccines and Antibodies 3Triple Analysis: Apoptosis, Cancer Vaccines and Antibodies 4Triple Analysis: Apoptosis, Cancer Vaccines and Antibodies 5GlaxoSmithKline Donates Scientific Equipment to Advance IDRI's Global Health Mission 2
(Date:4/25/2015)... New Jersey (PRWEB) April 25, 2015 ... people aged twelve and above needed treatment for an ... according to the Substance Abuse and Mental Health Services ... September 2011). Beyond these alarming numbers are harrowing stories ... by substance abuse . David H. Kerr ...
(Date:4/25/2015)... April 25, 2015 The federal ... mesh lawsuits filed against C.R. Bard, Inc. continues ... Southern District of West Virginia. According to a ... was convened that day, after certain defendants submitted ... Complaint. The Order directed that any Preliminary Motions ...
(Date:4/25/2015)... Carinsurancequotesinfo.com has released a new blog post that ... for flatbed trucks. , Flatbed trucks are ... They are mainly used for commercial purposes and thus ... explains that by comparing multiple offers, drivers can find ... vehicles. , It is now possible to compare free ...
(Date:4/25/2015)... By definition, a CIO’s responsibility is to support the ... their judgement and expertise to keep digital assets and environments ... article published in National Mortgage News on April 22nd, 2015 ... to their responsibilities by focusing too heavily on making sure ... it comes to company policy and industry best practices, and ...
(Date:4/25/2015)... The impact of the Trivedi Master ... of the public and is likely to cause further, ... and June. From March 21st to March 31st, ... "Special Prayers." More than 600 people participated in the ... and have reported intense experiences that they attest have ...
Breaking Medicine News(10 mins):Health News:New Book Features Powerful Stories of People Who Overcame Addiction 2Health News:New Book Features Powerful Stories of People Who Overcame Addiction 3Health News:C.R. Bard Vaginal Mesh Lawsuit News: Federal Litigation Issues New Pretrial Order Following Submission of Amended Responses to Master Complaint 2Health News:C.R. Bard Vaginal Mesh Lawsuit News: Federal Litigation Issues New Pretrial Order Following Submission of Amended Responses to Master Complaint 3Health News:C.R. Bard Vaginal Mesh Lawsuit News: Federal Litigation Issues New Pretrial Order Following Submission of Amended Responses to Master Complaint 4Health News:Auto Insurance Quotes for Flatbed Trucks Available Online! 2Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 2Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 3Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 4Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 5Health News:Trivedi Master Wellness™ Announces the Resounding Success of their Special Prayers Human Wellness Program 2Health News:Trivedi Master Wellness™ Announces the Resounding Success of their Special Prayers Human Wellness Program 3
... The following is a,statement of SEIU spokesperson Andrew McDonald:, ... health and,vitality of any democratic organization., "For the last ... and full debate over the future of our union. For ... been the subject of,an even more vigorous debate -- in ...
... China, April 8, 2008 /Xinhua-PRNewswire-FirstCall/ --,Linkwell Corporation (Linkwell ... developer, manufacturer and distributor of healthcare related,disinfectants in ... year-end,financial results in a conference call on Wednesday, ... Company will release its 2007 year-end financial results ...
... rising on,everything from bread to education, and health care is ... a Medicaid patient in the home, the,urgent need for an ... to nurses and other home care advocates,visiting legislators today as ... cost of a nurse,s visit to a home care patient ...
... Mark your calendars for these,training and networking ... Detroit Chapter (IABC/Detroit)!, April 16 Luncheon Session: ... organization,s message impact its market,share? Find out when ... messaging has impacted today,s marketing landscape., Join ...
... School of Medicine and colleagues at Merck Serono Research ... receptor sites on some tumors in different places at ... combination therapy for certain types of cancer. , An ... called epidermal growth factor receptors (EGFR) sitting on their ...
... Newborns Vulnerable for Rare,Metabolic Conditions, WASHINGTON, April 8, ... the Bills to four consecutive Super,Bowls, will be on ... with,Members of Congress asking them to approve and fund ... also participate in a press event with Senators Christopher,Dodd ...
Cached Medicine News:Health News:Linkwell Corporation Year-End 2007 Earnings Release and Conference Call Notice 2Health News:Bayada Nurses Advocates for Increase in Medicaid Reimbursement Rate to Allow More Individuals to Receive Home Care and Hire More Skilled Staff 2Health News:IABC/Detroit Announces April Professional Development and Networking Events 2Health News:Double binding sites on tumor target may provide future combination therapy 2Health News:Pro Football Hall of Fame Member Jim Kelly Urges Congress to Approve the Newborn Screening Saves Lives Act 2Health News:Pro Football Hall of Fame Member Jim Kelly Urges Congress to Approve the Newborn Screening Saves Lives Act 3Health News:Pro Football Hall of Fame Member Jim Kelly Urges Congress to Approve the Newborn Screening Saves Lives Act 4
... offers state-of-the-art quality in an instrument of ... durability. Low profile cutting tips allow access ... I instruments are available in just about ... required for large and small joint arthroscopic ...
... I Instrument program offers state-of-the-art quality in ... maintaining strength and durability. Low profile cutting ... joint spaces. Series I instruments are available ... size and angle required for large and ...
... program offers state-of-the-art quality in an instrument ... and durability. Low profile cutting tips allow ... Series I instruments are available in just ... angle required for large and small joint ...
... The Series I Instrument program offers ... low profile, while maintaining strength and durability. ... pathology in tight joint spaces. Series I ... cutting tip style, size and angle required ...
Medicine Products: