Tag Archives: PDUFA

December, 2017

  • 14 December

    FDA Extends Action Date for Xeljanz sNDA in Ulcerative Colitis

    NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib), an oral treatment under investigation for adult patients with moderately to severely active ulcerative colitis (UC). The …

September, 2016

  • 15 September

    FDA Extends PDUFA Date for Lexicon’s Carcinoid Syndrome Drug

    THE WOODLANDS, Texas, Sept. 14, 2016 /PRNewswire/ — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (“FDA”) will require additional time to complete its review of the New Drug Application (“NDA”) for telotristat etiprate, an oral drug for the treatment of carcinoid syndrome.  In …