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BRIEF-Pfizer announces U.S. FDA filing acceptance of supplemental new drug application for Xeljanz
May 3, 2017 / 1:12 PM / in 3 months

BRIEF-Pfizer announces U.S. FDA filing acceptance of supplemental new drug application for Xeljanz

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May 3 (Reuters) - Pfizer Inc

* Pfizer announces U.S. FDA filing acceptance of supplemental new drug application for Xeljanz (tofacitinib citrate) for the treatment of adult patients with active psoriatic arthritis

* FDA has provided an anticipated prescription drug user fee act (PDUFA) action date in December 2017 for SNDAS

* Both studies met primary endpoints showing statistically significant improvement with Xeljanz 5 mg,10 mg bid compared to placebo treatment

* A separate SNDA was also accepted for Xeljanz XR extended release 11 mg once daily use in PSA Source text for Eikon: Further company coverage:

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