FDA accepts ARIAD’s ponatinib NDA for filing
Published on October 25, 2012 at 2:00 AM
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for accelerated review of ARIAD's investigational BCR-ABL inhibitor, ponatinib, in patients with resistant or intolerant chronic myeloid leukemia (CML) or Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
The FDA also has granted ARIAD's request for Priority Review, which is given to investigational medicines that have the potential for providing significant improvement in the treatment, prevention, or diagnosis of a disease. The FDA has established an action date of March 27, 2013 under the Prescription Drug User Fee Act (PDUFA).
ARIAD Pharmaceuticals, Inc.