Ilex/Sanofi Zyrkamine (mitoguazone) user fee deadline postponed; committee review to be rescheduled.
Executive Summary
ILEX SUBMITS ADDITIONAL ZYRKAMINE DATA TO FDA, POSTPONING USER FEE DEADLINE from the decision date originally set for the end of April. Ilex said it is awaiting a determination of the new user fee date. Ilex submitted its NDA on Oct. 28 for accelerated approval of Zyrkamine (mitoguazone, methyl-glyoxal-bisguanylhydrazone) for treatment of patients with AIDS-related non-Hodgkin's lymphoma who have failed on another therapy.