版本:
中国

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

May 3 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:

我们的标准: 汤森路透“信任原则

更多 公司新闻(英文)

热门文章

编辑推荐

文章推荐