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FDA announces new supplies of short cancer drugs, drug maker requirements

February 21, 2012

Hospira Inc. today began shipping to hospitals and treatment centers 31,000 vials of a new preservative-free version of methotrexate, a critically short drug used to treat acute lymphoblastic leukemia in children, the Food and Drug Administration announced today. In March, APP Pharmaceuticals also will begin distributing a new preservative-free version of the drug, FDA said, urging hospitals to order only what they need to help preserve supplies. In addition, the agency will allow the temporary import of Lipodox as a substitute for the shortage drug Doxil, used to treat ovarian and other cancers. In related news, FDA issued draft guidance detailing requirements for drug makers to notify the agency of issues that could result in drug shortages. FDA Commissioner Margaret Hamburg, M.D., also urged Congress to pass the Preserving Access to Life Saving Medications Act (S. 296/ H.R. 2245), AHA-supported legislation that would give the agency new tools to help prevent and manage drug shortages. She said the agency last year prevented 195 drug shortages largely due to the increased awareness of the importance of early notification resulting from President Obama's October executive order.