Skip to main content

Remicade FDA 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 timeline for Remicade

Sep 26, 2011Approval FDA Approves Remicade to Treat Ulcerative Colitis in Children Older than 6 Years

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.