Skip to main content

Enbrel FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 19, 2019.

FDA Approved: Yes (First approved November 2, 1998)
Brand name: Enbrel
Generic name: etanercept
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis

Enbrel (etanercept) is a tumor necrosis factor (TNF) blocker for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

FDA Approval History for Enbrel

  • Nov 2, 1998 - approved for rheumatoid arthritis
  • May 27, 1999 - approved for polyarticular juvenile idiopathic arthritis
  • Jan 15, 2002 - approved for psoriatic arthritis
  • Jul 24, 2003 - approved for ankylosing spondylitis
  • Apr 30, 2004 - approved for plaque psoriasis
  • Nov 4, 2016 - approved for pediatric plaque psoriasis.

Development timeline for Enbrel

Nov  4, 2016Approval FDA Approves Expanded Use of Enbrel (etanercept) to Treat Children with Chronic Moderate-To-Severe Plaque Psoriasis

Further information

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