MLV Commnets On FDA Approval For SuperGen New Drug Application

According to MLV, SuperGen SUPG and its U.S. collaborative partner Eisai announced that the FDA has accepted the supplemental New Drug Application (sNDA) of Dacogen for the treatment of acute myeloid leukemia. MLV said that it expects the FDA to assign a PDUFA date of next March, 2012, based on the sNDA submission on May 6, 2011, and its anticipation for a standard 10-month review from the FDA. “We also expect Johnson & Johnson (JNJ; Not covered), SuperGen's ex-U.S. collaborative partner of Dacogen, to file a Marketing Authorization Application (MAA) for the treatment of elderly AML in the E.U. this year.” SuperGen closed yesterday at $3.09.