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