Skip to main content

Xeljanz FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 14, 2021.

FDA Approved: Yes (First approved November 6, 2012)
Brand name: Xeljanz
Generic name: tofacitinib
Dosage form: Tablets and Oral Solution
Company: Pfizer Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Ulcerative Colitis, Juvenile Idiopathic Arthritis, Ankylosing Spondylitis

Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor used for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis.

Development timeline for Xeljanz

DateArticle
Dec 14, 2021Approval U.S. FDA Approves Pfizer’s Xeljanz (tofacitinib) for the Treatment of Active Ankylosing Spondylitis
Sep 28, 2020Approval U.S. FDA Approves Pfizer’s Xeljanz (tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis
May 30, 2018Approval Pfizer Announces U.S. FDA Approves Xeljanz (tofacitinib) for the Treatment of Moderately to Severely Active Ulcerative Colitis
Dec 14, 2017Approval Pfizer Announces FDA Approval of Xeljanz (tofacitinib) and Xeljanz XR for the Treatment of Active Psoriatic Arthritis
Nov  6, 2012Approval FDA Approves Xeljanz for Rheumatoid Arthritis
Aug 21, 2012U.S. Food And Drug Administration Extends Action Date For Tofacitinib New Drug Application By Three Months
May  9, 2012FDA Arthritis Advisory Committee Recommends Approval of Tofacitinib for Adult Patients with Moderately to Severely Active Rheumatoid Arthritis
Dec 20, 2011Pfizer Announces FDA Acceptance for Review of New Drug Application for Tofacitinib for Adult Patients with Moderately to Severely Active Rheumatoid Arthritis

See also

Xeljanz (tofacitinib) Consumer information

Further information

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

Medical Disclaimer