Navigation Links
FDA Advisory Committee Recommends Approval of REMICADE® for Treatment of Pediatric Ulcerative Colitis
Date:7/21/2011

ing.  REMICADE® is a two-hour infusion administered every 6 or 8 weeks (indication-dependent), following a standard induction regimen that requires treatment at weeks 0, 2 and 6.  As a result, REMICADE® patients may require as few as six treatments each year as maintenance therapy.

Janssen Biotech, Inc. discovered and developed REMICADE® and markets the product in the United States.  The Janssen Pharmaceutical Companies market REMICADE® in Canada, Central and South America, the Middle East, Africa and Asia Pacific.  

In Japan, Indonesia, and Taiwan, Janssen Biotech, Inc. licenses distribution rights to REMICADE® to Mitsubishi Tanabe Pharma Corporation.  In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to REMICADE® to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co, Inc.  

Important Safety Information  

Only a doctor can recommend a course of treatment after checking a patient's health condition. REMICADE® (infliximab) can cause serious side effects such as lowering your ability to fight infections.  There are reports of serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis.  Some of these infections have been fatal.  Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE®.

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. A rare form of fatal lymphoma has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking REMICADE® and azathioprine or 6-mercaptopurine.  For children and adults taking TNF blockers, including REMICADE®, the chances of getting lymphoma or other cancers may increase.

Patients should discuss any concerns about their
'/>"/>

SOURCE Janssen Biotech, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. FDA Advisory Committees Recommend Continued U.S. Marketing Authorization for Trasylol(R)
2. Statement by KCP Chairman Dr. Edward Jones in Response to FDA Advisory Committee on Benefits and Risks of Erythropoietin-Stimulating Agents in Treatment of Kidney Patients
3. Targeted Genetics Reports on Recombinant DNA Advisory Committee (RAC) Review of its Phase 1/2 Trial of tgAAC94 for Rheumatoid Arthritis
4. Schiffrin Barroway Topaz & Kessler, LLP and Janet Jenner & Suggs, LLC Comment on Conagra Advisory Regarding Pot Pies Linked to Salmonella Outbreak
5. Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation
6. FDA Advisory Committee Supports Efficacy and Safety of Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment
7. HUYA Bioscience Intl Announces World-Class Clinical Advisory Team for New Anti-Arrhythmic Compound Sourced From China
8. FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent
9. Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote
10. UBC Forms European Advisory Board to Enhance Data Quality of CNS Trials
11. FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/20/2014)... DIEGO , Oct. 20, 2014   BioNano Genomics ... Irys system: the ability to collect human data at 30X ... a single chip.  This new capability was established and demonstrated ... the Irys TM System and will be ... two months. BioNano will be showcasing this advancement at the ...
(Date:10/20/2014)... DIEGO , Oct. 20, 2014 ... industry leader in bioactive lipid-targeted therapeutics, received official notification ... has been granted another key patent supporting its ... newly issued patent, European patent No. 2087002, claims ... substance in Lpath,s two lead compounds, iSONEP and ...
(Date:10/20/2014)... -- Norgine B.V. today announced that the ... preparation, NER1006, presented at the 79 th Annual ... Philadelphia, PA , has met its ... endpoint of cleansing success. The study demonstrated high quality ... in screening colonoscopy patients. [1] (Logo: ...
Breaking Medicine Technology:BioNano Genomics Announces One Human : One Chip : One Day 2BioNano Genomics Announces One Human : One Chip : One Day 3Lpath Granted Key European Patent Related to iSONEP and ASONEP Programs 2Lpath Granted Key European Patent Related to iSONEP and ASONEP Programs 3Lpath Granted Key European Patent Related to iSONEP and ASONEP Programs 4Positive Results from Phase II Data Show NER1006 Achieves High Quality Bowel Cleansing Efficacy 2
... DIEGO , May 26 Anadys Pharmaceuticals, Inc. ... Lazard Freres & Co. LLC as its strategic advisor as ... stockholders from its non-nucleoside polymerase inhibitor, ANA598, in development for ... and antiviral response data at the conclusion of 12 weeks ...
... Agency,s consumer health information , , , ... May 26 The U.S. Food and Drug Administration announced today that it ... information. , , , ... , , ...
Cached Medicine Technology:Anadys Retains Lazard as Strategic Advisor 2Anadys Retains Lazard as Strategic Advisor 3Anadys Retains Lazard as Strategic Advisor 4Anadys Retains Lazard as Strategic Advisor 5FDA Announces Collaboration With Drugs.com 2
(Date:10/20/2014)... 20, 2014 With a mere 19 ... Crist made a brief fundraising stop at the ... , Fresh from a debate last night with his ... stage for the first seven minutes because Crist had ... described the incident in one word: "weird." , Before ...
(Date:10/20/2014)... 2014 T.E.N., a technology and ... today that William H. Murray, renowned author and ... Luminary Leadership Award winner. Presented annually, the ISE® ... outstanding leader and industry practitioner for his or ... the information security industry. , Formerly with IBM, ...
(Date:10/20/2014)... 2014 Principle Business Enterprises, a family ... manufacturing top-of-the-line absorbent products. The company has recently ... popular brand, Tranquility® Premium Protection absorbent products. The ... gave its packaging a new look, and is currently ... to the public. , The new website, developed with ...
(Date:10/20/2014)... 20, 2014 Based on a ... only imaging assays capable of determining DNA sequence, ... With these three dimensions of high-resolution data, dGH ... the widest range of disease-causing genetic rearrangements, including ... other genomic tools, including today’s advanced sequencing technologies. ...
(Date:10/20/2014)... 2014 Punzoné , the first line ... has a lot to celebrate this month. October marks Italian ... achievements and contributions of Americans of Italian heritage and Italians ... today it shares its favorite Italian cocktails and encourages everyone ... - even if it is only in a glass. ...
Breaking Medicine News(10 mins):Health News:At Crist Fundraiser, Dan Newlin Says, "No More Robert Germans," Will Seek Changes to Florida Missing Persons Law 2Health News:At Crist Fundraiser, Dan Newlin Says, "No More Robert Germans," Will Seek Changes to Florida Missing Persons Law 3Health News:Bill Murray named 2014 ISE® Luminary Leadership Award Winner 2Health News:Bill Murray named 2014 ISE® Luminary Leadership Award Winner 3Health News:Bill Murray named 2014 ISE® Luminary Leadership Award Winner 4Health News:Tranquility® Premium Protection Incontinence Products Releases New Logo and Website 2Health News:KromaTiD Launches Genome Screening and Discovery Services 2Health News:KromaTiD Launches Genome Screening and Discovery Services 3Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 2Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 3Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 4
... Attorney General Eric Holder announced today that ... in Recovery Act formula grants for Florida state victim assistance ... in his remarks at the National Crime Victims, Rights Week ... Raton, Fla., for his efforts on behalf of ...
... same that sickened seven people in California, Texas , , FRIDAY, ... Friday to try to contain a swine flu outbreak that ... and sickened more than 900 other people in recent weeks. ... the start of a flu pandemic, according to published reports. ...
... thousand homecare workers won a partial victory today as an ... cuts "perverse" and ordered the board to lessen the severity ... six months to a smaller cut over a period not ... new proposal last week to cut healthcare for the workers ...
... are going unmet, , , FRIDAY, April 24 (HealthDay News) ... for them, want more attention paid to their psychological ... and their caretakers suffer in a variety of ways," ... at the University of Colorado Health Sciences Center, who ...
... the role of prostaglandins a family of fatty ... pressure maintenance, researchers at the University of Pennsylvania School ... the receptor for one type of prostaglandin have lower ... , The results indicate that the normal role ...
... 99 Percent for PUR Faucet Filters and More Than ... Associated Press issued a new report on ... water. Pharmaceuticals have now been detected in the drinking ... scientists have found no evidence of adverse health effects ...
Cached Medicine News:Health News:Attorney General Eric Holder Honors Florida Doctor and Announces $4.7 Million in Recovery Act Funds for State 2Health News:At Least 20 Dead, Hundreds Ill in Swine Flu Outbreak in Mexico 2Health News:At Least 20 Dead, Hundreds Ill in Swine Flu Outbreak in Mexico 3Health News:At Least 20 Dead, Hundreds Ill in Swine Flu Outbreak in Mexico 4Health News:At Least 20 Dead, Hundreds Ill in Swine Flu Outbreak in Mexico 5Health News:Arbitrator Calls Fresno Board of Supervisors' Planned Cuts to Homecare Workers 'Perverse'; Orders Cuts Reduced 2Health News:Reduce Suffering, Urge Heart Failure Patients and Caregivers 2Health News:Reduce Suffering, Urge Heart Failure Patients and Caregivers 3Health News:New target for maintaining healthy blood pressure discovered 2Health News:New target for maintaining healthy blood pressure discovered 3Health News:PUR Water Filtration Systems Can Reduce Trace Levels of Pharmaceuticals Found in Some U.S. Tap Water 2Health News:PUR Water Filtration Systems Can Reduce Trace Levels of Pharmaceuticals Found in Some U.S. Tap Water 3
... The Original LMA™ Airway., ,Launched in ... its use is now standard practice in ... patients worldwide the LMA Classic™ is a ... , ,The LMA Classic™ can be ...
... The Intubating LMA™ Airway. , ... or unexpected difficult airway, the LMA Fastrach™ ... without moving the head or neck. The ... attempts. , ,Selected by emergency teams ...
... The King LT™ is a superior, ... latest technological advances in materials and design ... The King LT™ emergency airway is a ... to provide emergency ventilation when direct laryngoscopy ...
... Soft amber latex. Available in even ... nasal airway maximizing patient comfort., ... way to maximize patient comfort while ... sensitivity. It is economically priced allowing ...
Medicine Products: