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

Date	Article
May 15, 2013	Approval FDA Approves Simponi to Treat Ulcerative Colitis
Apr 24, 2009	Approval Simponi (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Jun 27, 2008	Centocor, Inc. Submits BLA to FDA for Golimumab in the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

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

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA