Ariad Pharmaceuticals, Inc. Completes Rolling Submission of New Drug Application for Ponatinib to the FDA
Published: Sep 28, 2012
CAMBRIDGE, Mass.--(BUSINESS WIRE)--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced it has completed the rolling submission of the New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib, to the U.S. Food and Drug Administration (FDA). ARIAD provided the FDA with remaining chemistry, manufacturing, and controls (CMC) data. ARIAD is seeking U.S. marketing approval of ponatinib in patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). The Company has requested accelerated approval and a priority review of the ponatinib application by the FDA.