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Xeljanz XR FDA Approval History

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

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

Development Timeline for Xeljanz XR

Dec 12, 2019ApprovalFDA Approves Xeljanz XR (tofacitinib) Extended-Release Tablets for the Treatment of Ulcerative Colitis
Dec 14, 2017ApprovalPfizer Announces FDA Approval of Xeljanz (tofacitinib) and Xeljanz XR for the Treatment of Active Psoriatic Arthritis
Feb 24, 2016ApprovalPfizer 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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