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Pfizer Says Priority Review Period Extended For NDA For Abrocitinib- Quick Facts

Pfizer Inc. (PFE) said Wednesday the FDA has extended the review period for the New Drug Application for its atopic dermatitis drug candidate Abrocitinib, with decision date extended by three months to early third quarter.

The review period for the Supplemental New Drug Applications for XELJANZ/ XELJANZ XR (tofacitinib) for the treatment of adult patients with active ankylosing spondylitis (AS) has also been extended by three months with a decision expected in early third qurter, 2021.

XELJANZ (tofacitinib) is approved in four indications including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ulcerative colitis (UC), and polyarticular course juvenile idiopathic arthritis (pcJIA).

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