Navigation Links
Centocor Ortho Biotech Inc. Submits Application to FDA Seeking REMICADE® Pediatric Ulcerative Colitis Indication
Date:12/29/2010

to bloody stools, severe diarrhea and frequent abdominal pain. Tiny open sores, or ulcers, form on the surface of the lining where they bleed and produce pus and mucus. Symptoms of the disease may lead to loss of appetite, subsequent weight loss, and fatigue.  UC is a chronic disease, and there is no cure.  Although progress has been made in inflammatory bowel disease (IBD) research, investigators do not know what causes this disease.

About REMICADE

REMICADE was the first anti-tumor necrosis factor (TNF)-alpha treatment to be approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology.  REMICADE has demonstrated broad clinical utility with indications in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), ulcerative colitis (UC), pediatric Crohn's disease (PCD) and psoriasis (PsO).  The safety and efficacy of REMICADE have been well established in clinical trials over the past 17 years and through commercial experience with more than one million patients treated worldwide.

In the U.S., REMICADE is approved for the following indications:

  • Reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active RA, when administered in combination with methotrexate.  
  • Reducing signs and symptoms in patients with active AS.
  • Reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatric patients with moderately to severely active CD who have had an inadequate response to conventional therapy.  
  • Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD.  
  • Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal heal
    '/>"/>

SOURCE Centocor Ortho Biotech Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis
2. Despite Managed Care Obstacles, Interest and Anticipated Use of Centocor Ortho-Biotechs New Psoriasis Agent Stelara (ustekinumab) is High
3. Centocor Ortho Biotech Inc. Submits Application to FDA Seeking to Expand SIMPONI® Label to Include Inhibition of Structural Damage in Treatment of Psoriatic Arthritis
4. Centocor Ortho Biotech Inc. Announces NDA Submission for Abiraterone Acetate for the Treatment of Metastatic Advanced Prostate Cancer
5. Ortho Biotech Reiterates Confidence in PROCRIT(R) (Epoetin alfa) Safety and Efficacy When Used According to Label
6. Isis Earns $5 Million Milestone Payment From Ortho-McNeil, Inc. for Initiation of Phase 1 Study of ISIS 325568
7. The OrthoGlide(TM) Medial Knee Implant Continues to be Accepted as an Alternative to Total Knee Replacement
8. Clinical Data Presented on OrthoGlide(R) Medial Knee Implant
9. ORTHO EVRA(R) Prescribing Information Updated
10. Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote
11. Data From Ortho Biotech-Sponsored Studies to be Presented at National Kidney Foundation 2008 Spring Clinical Meetings
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/27/2015)... March 27, 2015 Concord Medical Services ... CCM ), a leading specialty hospital management ... of radiotherapy and diagnostic imaging centers in ... of a purchase agreement under which Concord Medical ... of the Company, agreed to acquire the Fortis ...
(Date:3/26/2015)... 2015  The Burzynski Research Institute, Inc. (BRI) announced ... by the Department of Surgery at Kurume University ... have been published. The study, a randomized non-blinded ... as post-operative adjuvant therapy with and without Antineoplastons ... A total of 65 patients, ...
(Date:3/26/2015)... PASADENA, Calif. , March 26, 2015 ... San Gabriel Valley to perform transcatheter aortic valve replacement ... TAVR procedure is a revolutionary new way to replace ... use of a heart lung machine. The ... heart team led by Azhil ( Alex) Durairaj , ...
Breaking Medicine Technology:Concord Medical Announces Acquisition of Fortis Surgical Hospital in Singapore 2Concord Medical Announces Acquisition of Fortis Surgical Hospital in Singapore 3Huntington Memorial Hospital Performs Groundbreaking Minimally Invasive Replacement of Heart Valves 2
... Schein, Inc. (Nasdaq: HSIC ), the largest provider ... today that it will release its third quarter 2010 financial ... 2010, and will provide a live webcast of its earnings ... Eastern Daylight Time. Speakers on the call will include Stanley ...
... PITTSBURGH, Oct. 15 Mylan Inc. (Nasdaq: ... Inc. received final approvals from the U.S. Food and ... (ANDAs) for the generic versions of Hyzaar® Tablets, 50 ... 25 mg, 50 mg and 100 mg, both antihypertensives. ...
Cached Medicine Technology:Henry Schein to Webcast Third Quarter 2010 Conference Call Friday, October 29, at 10:00 a.m. EDT 2Mylan Receives Approvals for Generic Versions of Hyzaar® and Cozaar® 2
(Date:3/27/2015)... PRUSSIA, PA and LONDON, UK (PRWEB) March 27, 2015 ... President of DrugDev SiteStart Melissa (Liss) Easy was named ... , The 40 Under 40 list spotlights 40 ... for their professional accomplishments and community involvement. Winners are ... in a special supplement of the Philadelphia Business Journal. ...
(Date:3/27/2015)... The report “CountryFocus: Healthcare, Regulatory and Reimbursement ... on and analysis of the healthcare, regulatory and reimbursement ... in 2013 amounted to 316.1 million, having grown at ... 2008. The country’s increasingly elderly population and corresponding increase ... boost the growth of the pharmaceutical market, which was ...
(Date:3/27/2015)... SMI (Silicon Microstructures, Inc.), a global MEMS pressure ... MEMS based ultra-miniature pressure sensor designed especially for the ... 220um x 75um provides ample space for 1-French catheter ... industry leading in vivo drift performance of 2 ... pressure range from 0 to 1,100 mmHg absolute. ...
(Date:3/27/2015)... 2015 When struck with the aftermath ... know where to begin. The latest eBook released ... attorney, offers accident victims a clear and concise process ... ensure their personal injury claim is seen through to ... first actions that should be taken immediately following the ...
(Date:3/27/2015)... To address their number one lawn care question which ... this video to explain the complicated dynamics between the light ... expected to thrive in, be it in dense building or ... Anytime a sun-loving plant is put in the shade the ... try to amend this issue by applying large quantities of ...
Breaking Medicine News(10 mins):Health News:DrugDev Founder Melissa Easy is 2015 Philadelphia Business Journal 40 Under 40 Honoree 2Health News:US Pharmaceutical Market worth $548.4 billion by 2020 Says a New Report Available at RnRMarketResearch.com 2Health News:US Pharmaceutical Market worth $548.4 billion by 2020 Says a New Report Available at RnRMarketResearch.com 3Health News:US Pharmaceutical Market worth $548.4 billion by 2020 Says a New Report Available at RnRMarketResearch.com 4Health News:SMI Launches Catheter Mountable Pressure Sensor 2Health News:Dax Jones Updated eBook on Trucking Accidents Offers Helpful Information to Crash Victims 2Health News:For Spring Turf Planting Season, Super-Sod Created a New How-To Video Entitled "Two Views on Shade and Turf" 2
... earlier Rhode Island Hospital study looking at data from ... per year were seen in emergency departments across the ... which examined emergency department visits from 2000 through 2005, ... the study period, an average of 88,563 each year. ...
... Shopping on the Internet may not be as environmentally friendly, ... and Traders are anything to go by. ... home deliveries has outweighed the reduction in carbon dioxide emissions ... said. ,The total CO2 emitted by cars fell ...
... the University of Southern California have identified a chemical ... brain to low blood sugar levels . ... to yield new insights in the fight against diabetes, ... the researchers, the chemical travels from the hindbrain, which ...
... in Massachusetts, resulting in calls mosquito spraying, though environmentalists ... a potentially deadly encephalitis. Though the incidence is rising, ... of objections from environmentalists. ,Nine regional control ... the time, the Norfolk County Mosquito Control Project, which ...
... found that grandchildren, who were taken care of by their ... of their grandparents as they age . ,The ... their grandparents and received their care and concern, were more ... ,"Even little things, like occasional babysitting for a ...
... made significant advances towards the development of a technique that ... variant CJD . ,The technique, which has so ... and accelerating the replication of prions - abnormal proteins that ... the disease. ,The method, known as known as ...
Cached Medicine News:Health News:Higher Rates of Trampoline Injuries 2Health News:Neurotransmitter That can Yield New Insights in the Fight Against Diabetes Identified 2Health News:Eastern Equine Encephalitis Spreading Its Tentacles in Massachusetts 2Health News:Eastern Equine Encephalitis Spreading Its Tentacles in Massachusetts 3Health News:Grandparents' Care Makes Grandchildren More Caring for Them 2Health News:Significant Advances in VCJD Prion Detection 2
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: