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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: Johnson & Johnson Innovative Medicine
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:

Development timeline for Simponi

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

Further information

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