FDA Commissioner Margaret Hamburg announced yesterday during a teleconference that the FDA has arranged to meet critical needs for methotrexate and Doxil® (doxorubicin).
FDA has approved temporarily importing Lipodox, which has the same active ingredient — doxorubicin — and the same concentration as Doxil. There should be enough to meet needs for Doxil treatment. FDA has inspected and approved the foreign plants that manufacture Lipodox.
APP Pharmaceuticals and Hospira both have ramped up production of methotrexate. Together they expect to be able to ship the drug immediately and have enough to meet future needs. Methotrexate is especially needed by children with leukemia where it can produce remissions rapidly and cure most children with acute lymphoblastic leukemia (ALL).
Unfortunately, fluorouracil (5-FU) and leucovorin are still in shortage. Read the rest of this entry »