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

HORSHAM, Pa., Dec. 29, 2010 /PRNewswire/ -- Centocor Ortho Biotech Inc. announced today that it has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) requesting the approval of REMICADE® (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.  REMICADE was designated orphan drug status by the FDA on November 12, 2003 for the treatment of pediatric UC.  REMICADE is currently approved for the treatment of adults with moderately to severely active UC who have not responded adequately to conventional therapy.  

The sBLA is supported by data from a pivotal Phase 3, randomized, open-label trial that assessed the safety and efficacy of induction and maintenance REMICADE treatment in pediatric patients age six through seventeen who were diagnosed with moderately to severely active UC.  Eligible patients had an inadequate response to treatment with conventional treatment with 6-mercaptopurine (6-MP), azathioprine (AZA), corticosteroids, and/or 5-aminosalicylate (5-ASA) treatments.  

"Data from the Phase 3 trial support the efficacy of REMICADE in inducing clinical response, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in pediatric patients with ulcerative colitis, an orphan disease that is in need of treatment options," said Jerome A. Boscia, M.D., Senior Vice President, Clinical R&D, Centocor Research & Development, Inc.  "We are pleased to work with the FDA as we seek approval of REMICADE for the treatment of this very challenging disease."

About Ulcerative Colitis (UC)

UC, a chronic inflammatory bowel disease affecting nearly 500,000 people in the U.S., is marked by the inflammation and ulceration of the colonic mucosa, or innermost lining, which may lead
'/>"/>

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:8/29/2014)... Aug. 29, 2014 /PRNewswire-iReach/ -- SAM Medical Products ... for the SAM Junctional Tourniquet.  ... SAM Medical Products announced today that it has ... address a potential issue with a clip used ... Axilla application of the SAM Junctional Tourniquet (SJT).  ...
(Date:8/29/2014)... , Aug. 29, 2014   Mast Therapeutics, ... company, announced today that Santosh Vetticaden, Chief Medical ... the Company, for personal reasons, in mid-September.  ... Officer of Aires Pharmaceuticals, which Mast acquired earlier ... as the Company,s interim Chief Medical Officer.  Dr. ...
(Date:8/29/2014)... Utah , Aug. 29, 2014  BC Technical, ... has acquired Polaris Medical Imaging, a leader in sales, ... This strategic acquisition allows BC Technical to continue to ... specifically within MR and CT modalities. ... service," said Mark Alvarez , president and CEO ...
Breaking Medicine Technology:SAM Medical Products Implements Voluntary Recall of its Accessory (Axilla) Strap for the SAM Junctional Tourniquet. 2Mast Therapeutics Announces Management Change 2Mast Therapeutics Announces Management Change 3Mast Therapeutics Announces Management Change 4BC Technical Acquires Polaris Medical Imaging 2
(Date:8/31/2014)... 31, 2014 To make it easy ... they can trust, NutriGold is shipping complimentary samples of ... has been set up to make taking advantage of ... According to Priya Khan, Director of Research and Development ... one of our products, they are entrusting us with ...
(Date:8/31/2014)... Rockville, MD (PRWEB) August 31, 2014 ... electronic health records (EHR) software firm that focuses ... overall practice success found a congruent commitment with ... In Sports . , “We create an environment ... and effortlessly, allowing more time with patients,” says ...
(Date:8/31/2014)... Richmond, CA (PRWEB) August 31, 2014 ... program of the California State Library, celebrates 30 ... and their families. Since its inception, California’s Library ... a million Californians learn to read and write. ... this volunteer-based program, the state is launching a ...
(Date:8/31/2014)... Wine only protects against cardiovascular disease (CVD) in people ... Veritas (IVV) study presented at ESC Congress today by ... Taborsky said: "This is the first randomised trial comparing ... of atherosclerosis (1) in people at mild to moderate ... was only protective in people who exercised. Red and ...
(Date:8/30/2014)... A retrievable and repositionable transcatheter aortic valve is ... according to research presented at ESC Congress 2014 ... direct flow medical (DFM) transcatheter aortic valve has ... the potential to improve transcatheter aortic valve implantation ... , Dr Pyxaras said: "TAVI is well established ...
Breaking Medicine News(10 mins):Health News:Whole-food Supplement Samples Now Offered by NutriGold 2Health News:Whole-food Supplement Samples Now Offered by NutriGold 3Health News:Powerhouse EHR, Future Health, Announces Gold Sponsorship of POWERPlay in Sports National Tour 2Health News:Powerhouse EHR, Future Health, Announces Gold Sponsorship of POWERPlay in Sports National Tour 3Health News:Powerhouse EHR, Future Health, Announces Gold Sponsorship of POWERPlay in Sports National Tour 4Health News:California Library Literacy Services Celebrates 30th Anniversary 2Health News:California Library Literacy Services Celebrates 30th Anniversary 3Health News:Wine only protects against CVD in people who exercise 2Health News:Retrievable transcatheter aortic valve effective and safe in real world setting 2
... Reporter , MONDAY, May 28 (HealthDay News) -- Updated ... good news for those at risk of osteoporosis, but ... other chronic diseases. While estrogen-only and estrogen-plus-progestin formulations ... for stroke and other conditions including gallbladder disease, according ...
... study suggests that aspirin and other similar painkillers may ... CANCER , a peer-reviewed journal of the American ... may be added to the benefits of these commonly ... anti-inflammatory drugs, or NSAIDs, which include aspirin, ibuprofen, and ...
... Reporter , MONDAY, May 28 (HealthDay News) -- Sensory ... increasingly used by occupational therapists to treat children with ... organization says there isn,t much evidence that such therapies ... the potential of sensory therapies -- it,s a ripe ...
... -- Picnics, parades and cookouts are as much a part ... war veterans. But, before tucking into that leafy, green ... vegetables can become contaminated with harmful pathogens that cause food ... listeria and norovirus, according to the Academy of ...
... -- Boosting students, levels of physical education improves their ... followed more than 200 schoolchildren, starting from first through ... to an intervention group that received physical education five ... such as balance and coordination. The other children were ...
... , FRIDAY, May 25 (HealthDay News) -- People ... colitis, may be at increased risk for flare-ups when ... or mountain climbing, a new study suggests. This ... involves the small intestine) or ulcerative colitis (which typically ...
Cached Medicine News:Health News:HRT Update: Therapy May Reduce Fractures, Boost Some Risks 2Health News:HRT Update: Therapy May Reduce Fractures, Boost Some Risks 3Health News:Commonly used painkillers may protect against skin cancer 2Health News:Doubt Cast on Usefulness of 'Sensory' Therapies for Autism 2Health News:Doubt Cast on Usefulness of 'Sensory' Therapies for Autism 3Health News:Keep Food Safety in Mind This Memorial Day Weekend 2Health News:Travel to High Altitudes Tied to Crohn's, Colitis Flare-Ups 2
... Monitor (PCM) and Central Station provide an ... extends the cardiac cath or electrophysiology lab ... and/or EP procedures, providing both physiomonitoring parameters ... either standalone or on its own network. ...
For the critical care environment, telemetry, emergency room and other monitoring areas....
DS 7600 Central Station...
... Gemini Family of infusion pumps ... a collective series of administration ... line offers a wide variety ... sets, each featuring the patented ...
Medicine Products: