Navigation Links
FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C
Date:3/11/2009

New use for PEGINTRON(TM) and REBETOL(R) offers certain patients a second chance to achieve treatment success

KENILWORTH, N.J., March 11 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has approved new labeling for PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) combination therapy for treating chronic hepatitis C in patients 3 years of age and older with compensated liver disease. With approval of this expanded indication, PEGINTRON and REBETOL is the first and only pegylated interferon combination therapy approved in the United States that is not restricted to treatment-naive patients. Patients less likely to benefit from retreatment after failing a course of therapy include those with previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, or HCV genotype 1 infection. It is estimated that more than 100,000 patients in the United States failed prior treatment of their hepatitis C virus (HCV) infection, representing a large and growing patient population.

"With the FDA approval of PEGINTRON and REBETOL combination therapy for this new indication, U.S. physicians now have a treatment option that offers a second chance for success to certain patients who failed prior therapy," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "This approval further underscores Schering-Plough's leadership and long-term commitment to developing new treatment options and innovative therapies to meet the needs of patients with hepatitis C."

Data from the clinical study supporting the approval helped to define those patient groups most likely to respond to retreatment as well as those unlikely to respond. Overall, p
'/>"/>

SOURCE Schering-Plough Corporation
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

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:9/17/2014)... LEIPZIG, Germany , Sept. 17, 2014 ... entered into an exclusive technology development partnership with ... agents to image CD4+ positive immune T cells. ... capability to precisely diagnose and determine therapeutic options ... The ability to image CD4+ T-cells will also ...
(Date:9/17/2014)... , Sept. 17, 2014   GS1 ... how to implement GS1 Standards to support the ... enhance patient safety and security in the pharmaceutical ... GS1 Standards to U.S. Pharmaceutical Supply Chain Business ... Act , was developed in collaboration with ...
(Date:9/17/2014)... Calif. , Sept. 17, 2014 ... announced that it has earned a $4 million ... AKAO ) associated with the initiation of a ... serious multi-drug resistant (MDR), gram-negative bacterial infections.  The ... study to evaluate the efficacy and safety of ...
Breaking Medicine Technology:ImaginAb Expands ImmunoPET Pipeline to Include CD4+ T-Cell Imaging 2New Healthcare Industry Guideline Delineates How to Implement GS1 Standards to Support Requirements of the 2013 Drug Supply Chain Security Act 2New Healthcare Industry Guideline Delineates How to Implement GS1 Standards to Support Requirements of the 2013 Drug Supply Chain Security Act 3New Healthcare Industry Guideline Delineates How to Implement GS1 Standards to Support Requirements of the 2013 Drug Supply Chain Security Act 4Isis Pharmaceuticals Earns $4 Million from Achaogen for the Initiation of a Phase 3 Study of Plazomicin 2Isis Pharmaceuticals Earns $4 Million from Achaogen for the Initiation of a Phase 3 Study of Plazomicin 3
(Date:9/18/2014)... Atlanta, GA (PRWEB) September 18, 2014 ... Counselor, recognizes that 1- sometimes, inner beauty has to ... strengths have to be acknowledged in order to be ... , Healing Hearts shows the world how to do ... Counseling and Life Coaching using the Healing Hearts system, ...
(Date:9/18/2014)... Mateo, CA (PRWEB) September 18, 2014 ... archiving solutions, from active, to medium, and even long ... of content for any length of time. This includes ... of machine-produced data. When used together, Nautilus and ASG-Digital ... managing archive content. , "storageFOUNDRY is pleased to ...
(Date:9/17/2014)... (PRWEB) September 18, 2014 Recently, UWDress.com, ... dresses and women’s special occasion outfits, has released its ... In addition, the firm has launched a big sale ... are now available at deeply discounted rates, from 15 ... that the company insists on using comfortable to wear ...
(Date:9/17/2014)... Charlotte, NC (PRWEB) September 18, 2014 ... , U.S. emergency departments treat an estimated 173,285 sports- ... and adolescents every year. Soon, a blood test may ... concussion is and how long recovery will take. ... reported that they have found a way to ...
(Date:9/17/2014)... According to an August 5, ... “Adverse Events Associated with Use of Enhancement Medical's ... use of Expression, a hyaluronic acid product, for ... including discoloration, lumps, bruising, nodules, and swelling. ... cosmetic use include Restylane , Juvéderm, Perlane, ...
Breaking Medicine News(10 mins):Health News:Suzaunna-Where Life! Happens Announces the Launch of Healing Hearts 2Health News:Suzaunna-Where Life! Happens Announces the Launch of Healing Hearts 3Health News:storageFOUNDRY and ASG Software Solutions Partner to Integrate ASG-Digital Archive with the Nautilus Software-Defined Storage Platform 2Health News:storageFOUNDRY and ASG Software Solutions Partner to Integrate ASG-Digital Archive with the Nautilus Software-Defined Storage Platform 3Health News:2014 Empire Waist Evening Dress Collection Now Unveiled At UWDress.com 2Health News:Breakthrough blood test will improve concussion diagnoses, treatment 2Health News:Breakthrough blood test will improve concussion diagnoses, treatment 3Health News:Simon Ourian, Kim Kardashian's Cosmetic Surgeon, Warns About Illegal Use of Expression as a Dermal Filler 2
... effort to uncover the medium- and large-scale genetic differences between ... a wide range of diseases, according to a paper by ... published in the May 10, 2007, Nature. The undertaking will ... says amount to as much as five to ten percent ...
... study examines the use of tissue-engineered scaffolding made of cartilage ... replace defective cartilage tissue. ,Cartilage cells are ... the body, where new cartilage tissue is grown along the ... ,The procedure was extremely successful in tested mice as ...
... immune systems of humans and opossums, the famous Australian ... breakthroughs in the understanding and treatment of facial tumours ... in the Australian island state of Tasmania. ... of genetic information of the South American opossum, the ...
... Breakthrough research has offered a clue as to why oral ... in persons not regarded as primary-risk candidates . American scientists ... passes on the human papillomavirus or HPV between partners and ... does not smoke, drink or use any substance known to ...
... study reveals that almost two-thirds of US children ... but very few of them experience post-traumatic stress ... resilience in children, but it also suggests that the ... said William Copeland of Duke University Medical Center, whose ...
... cervical cancer is nearly 100 percent effective against the two ... cases of cervical cancer. Results of a nationwide study of ... of the New England Journal of Medicine. ,But ... three shots of a new HPV vaccine marketed by Merck ...
Cached Medicine News:Health News:Cataloging the Structural Variations in Human Genetics 2Health News:Cataloging the Structural Variations in Human Genetics 3Health News:Treatment of Premature Babies, Opossums Could Help 2Health News:Swallowing The Bitter Pill-Oral Sex Linked To Oral Cancer 2Health News:Two-thirds of US Children Experience Trauma, but Recover Fast 2Health News:Study Shows Continued Success for New HPV Vaccine Against Virus 2
... high-end microplate reader with outstanding sensitivity and ... Fluorescence Intensity - FRET , Fluorescence Polarization ... , Luminescence , , , ... reader with fastest read times. The ultimate ...
GENios Pro, TECANs advanced, multi-functional injector reader offers simultaneous reagent dispensing and detection for monitoring of fast kinetic reactions...
... Throughput Screening (UHTS), Analyst GT delivers ... for smooth transfer of assays into ... all the detection modalities of Analyst ... polarization, time-resolved fluorescence, luminescence, absorbance, as ...
... a fully automated microplate based multi-detection ... principles:, , Fluorescence Polarization , ... , High-Performance Luminescence (flash and glow) ... is designed for the widest possible ...
Medicine Products: