Xeljanz Approval History

  • FDA approved: Yes (First approved November 6th, 2012)
  • Brand name: Xeljanz
  • Generic name: tofacitinib
  • Company: Pfizer Inc.
  • Treatment for: Rheumatoid Arthritis

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

FDA Approval History for Xeljanz

DateArticle
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

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