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:7/10/2014)... , July 10, 2014  Valeant Pharmaceuticals International, Inc. ... announced it has completed the sale to Galderma of ... owned or held by Valeant for $1.4 billion in ... S.A, which recently completed its acquisition of Galderma. ... of our products to a company that is firmly ...
(Date:7/10/2014)... 2014  Decision Resources Group finds that while ... specialists are willing to prescribe Durata,s Dalvance (dalbavancin) ... as OPAT, approximately two-thirds of the respondents reported ... hospital inpatients. However, our findings indicate that nearly ... on OPAT following hospital discharge, and most are ...
(Date:7/10/2014)... , July 10, 2014 CVS Caremark Corporation (NYSE: ... directors has approved a quarterly dividend of $0.275 (27.5 cents) ... payable on August 1, 2014, to holders of record on ... CVS Caremark is dedicated to helping people on their ... in the United States . Through 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) 3
... Omthera Pharmaceuticals, Inc., a privately-held emerging specialty ... and Chief Executive Officer, will present at the ... InterContinental Boston, in Boston, Massachusetts, on Wednesday, June ... About Omthera Pharmaceuticals, Inc.Founded in 2008, Omthera ...
... Alere Inc. (NYSE: ALR ) (the "Company") ... each of its consent solicitations commenced on May 31, ... the "Proposed Modifications") governing its 9.0% Senior Subordinated Notes ... due 2018 (the "8.625% Notes") and 7.875% Senior Notes ...
Cached Medicine Technology:
(Date:7/11/2014)... Europe Well Intervention Market report defines and segments the well ... The well intervention services market in Europe is estimated to ... by 2018, at a CAGR of 7% from 2013 to ... Intervention Market report, to get an idea of the in-depth ... in the Europe well intervention market, and is supported by ...
(Date:7/11/2014)... News) -- In people with sex addiction, pornography affects ... seen in drug addicts as they consume drugs, a ... brain activity between patients who have compulsive sexual behavior ... addicts," study author Dr. Valerie Voon, of the University ... release. Voon,s research involved 19 men with sex ...
(Date:7/11/2014)... The report “Probiotics Market by Products (Functional ... (Regular, Therapeutic, Preventive Health Care) & Ingredients (Lactobacilli, ... 2019 ” defines and segments the global probiotics ... market value of probiotic products and ingredients. The ... for the global market with an analysis of ...
(Date:7/11/2014)... 2014 Biostimulants are widely applied in ... and ornamentals. These also help turf and ornamentals in ... roots. Turf, ornamentals, and flowers appear healthy and strong ... has increased from the last few years. The most ... is Europe, with around 40% share in 2013, and ...
(Date:7/11/2014)... 2014) Obese and overweight firefighters are not ... providers, according to new research from The University ... , National guidelines state that health care professionals ... maintaining a healthy weight. Firefighters have high rates ... cause of line-of-duty deaths in firefighters. This study ...
Breaking Medicine News(10 mins):Health News:Europe Well Intervention Services Market is Expected to Reach $3.4 Billion by 2018 - New Report by MicroMarket Monitor 2Health News:Europe Well Intervention Services Market is Expected to Reach $3.4 Billion by 2018 - New Report by MicroMarket Monitor 3Health News:Brains of Sex Addicts May Be Wired Like Those of Drug Addicts, Study Finds 2Health News:Probiotic Ingredient Market worth $1,732.8 Million by 2019 - A Report by MarketsandMarkets 2Health News:Probiotic Ingredient Market worth $1,732.8 Million by 2019 - A Report by MarketsandMarkets 3Health News:Probiotic Ingredient Market worth $1,732.8 Million by 2019 - A Report by MarketsandMarkets 4Health News:Probiotic Ingredient Market worth $1,732.8 Million by 2019 - A Report by MarketsandMarkets 5Health News:Biostimulants Market in Turf and Ornamentals is Expected to Reach $ 3.8 Billion by 2018 - New Report by MicroMarket Monitor 2Health News:Biostimulants Market in Turf and Ornamentals is Expected to Reach $ 3.8 Billion by 2018 - New Report by MicroMarket Monitor 3
... innovative approach to treating neonatal feeding problems at Nationwide ... feed orally to be discharged earlier and without feeding ... According to American Academy of Pediatrics guidelines, in ... hospital, they must establish safe oral feeding methods. The ...
... This press release is available in German . ... the biggest risk factors for the development of gastric cancer, the ... biologists from the University of Zurich have now identified a mechanism ... gastric mucosa and sets them up for malignant transformation. Gastric ...
... -- Doctors have been prescribing codeine for postpartum pain management ... to breastfeed while taking the opioid. But the death ... many health care providers questioning the safety of the drug ... risks, some doctors have begun the practice of prescribing oxycodone ...
... HealthDay Reporter , MONDAY, Sept. 5 (HealthDay News) -- Living ... as much as 80 percent, researchers from the U.S. National ... diet, exercise, smoking and drinking have an impact on whether ... each individual factor affects the risk had been unclear. ...
... 6 (HealthDay News) -- There,s no link between menopause ... a study that challenges a long-held medical belief that ... menopause. Aging alone, not the hormonal impact of ... women, according to the Johns Hopkins researchers. The ...
... Sept. 6 (HealthDay News) -- Some children, especially those ... the hospital, a new study finds. Acetaminophen, albuterol ... hospitalized children, the researchers said. They also found an ... of drugs given to children. On the first ...
Cached Medicine News:Health News:Neonatal and infant feeding disorders program saves infants from lifetime of feeding tubes 2Health News:Stomach bacterium damages human DNA 2Health News:Mother's postpartum oxycodone use: No safer for breastfed infants than codeine 2Health News:Healthy Living Can Cut Chances of Developing Diabetes 2Health News:Aging, Not Menopause, Raises Women's Heart Risks, Study Finds 2Health News:Hospitalized Kids May Receive Up to 35 Meds a Week 2
... Beta 200 ophthalmoscope, ... glare-free direct ophthalmoscope. Heine's ... patent #4,963,014) along with ... construction, make the Beta ...
... optics. The separation of illumination and observation ... system avoids corneal and iris reflex (Gullstrand-principle). ... the whole of the illuminated section of ... Conventional ophthalmoscopes often let you see only ...
... Beta 200S is the first ... combination of patented aspherical optics ... range of corrective lenses from ... single diopter steps. A perfectly-focused ...
With the unique automatic focus system, Autofoc 2 remains the instrument of choice for direct ophthalmoscopy. Includes XHL halogen bulb....
Medicine Products: