Remicade Approval History
FDA Approved: Yes (First approved August 24, 1998)
Brand name: Remicade
Generic name: infliximab
Dosage form: Injection
Company: Janssen Biotech Inc.
Treatment for: Crohn's Disease, Acute, Crohn's Disease, Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Psoriasis
Remicade (infliximab) is a tumor necrosis factor (TNF) blocker indicated for use in the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
FDA Approval History for Remicade
- Aug 24, 1998 - approved for Crohn's disease
- Nov 10, 1999 - approved in combination with methotrexate for rheumatoid arthritis
- Dec 17, 2004 - approved for ankylosing spondylitis
- May 13, 2005 - approved for psoriatic arthritis
- Sep 15, 2005 - approved for ulcerative colitis
- May 19, 2006 - approved for pediatric Crohn's disease
- Sep 26, 2006 - approved for plaque psoriasis
- Sep 23, 2011 - approved for pediatric ulcerative colitis
Development History and FDA Approval Process for Remicade
|Sep 26, 2011||FDA Approves Remicade to Treat Ulcerative Colitis in Children Older than 6 Years|
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