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Xeljanz XR FDA Approval History

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

FDA Approved: Yes (First approved February 23, 2016)
Brand name: Xeljanz XR
Generic name: tofacitinib
Dosage form: Extended-Release Tablets
Company: Pfizer Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis

Xeljanz XR (tofacitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

Development timeline for Xeljanz XR

Dec 14, 2021Approval U.S. FDA Approves Pfizer’s Xeljanz (tofacitinib) for the Treatment of Active Ankylosing Spondylitis
Dec 12, 2019Approval FDA Approves Xeljanz XR (tofacitinib) Extended-Release Tablets for the Treatment of 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

Further information

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