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Xeljanz Approval History

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

Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, and moderately to severely active ulcerative colitis.

Development History and FDA Approval Process for Xeljanz

DateArticle
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
Feb 24, 2016Approval Pfizer Announces FDA Approval of Xeljanz XR (tofacitinib citrate), the First and Only Once-Daily Oral JAK Inhibitor Treatment for Rheumatoid 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

Further information

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