Simponi FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 28, 2021.
FDA Approved: Yes (First approved April 24, 2009)
Brand name: Simponi
Generic name: golimumab
Dosage form: Injection
Company: Centocor, Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis
Simponi (golimumab) is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with:
- Moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate
- Active psoriatic arthritis (PsA) alone, or in combination with methotrexate
- Active ankylosing spondylitis (AS)
- Moderate to severe Ulcerative colitis (UC) with an inadequate response or intolerant to prior treatment or requiring continuous steroid therapy
- inducing and maintaining clinical response
- improving endoscopic appearance of the mucosa during induction
- inducing clinical remission
- achieving and sustaining clinical remission in induction responders
Development timeline for Simponi
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