ARTICLE | Clinical News
FDA panel backs Pfizer's Xeljanz for psoriatic arthritis
August 4, 2017 7:54 PM UTC
FDA’s Arthritis Advisory Committee voted 10 to 1 recommending approval of sNDAs from Pfizer Inc. (NYSE:PFE) for Xeljanz (Jaquinus) tofacitinib and Xeljanz XR extended release to treat adults with active psoriatic arthritis. The committee recommended Xeljanz at a dose of 5 mg twice daily and Xeljanz XR at 11 mg once daily.
Pfizer said FDA accepted the sNDAs for review in May, with an anticipated PDUFA date for the sNDAs in December...
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