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New drug suppliers OK’d amid cancer drug shortages

FDA acts to help cancer patients

TRENTON, N.J. - Federal regulators have approved new suppliers for two crucial cancer drugs, easing critical shortages that had been ratcheting up fears that patients, particularly children with leukemia, would miss lifesaving treatments.

But there are 283 prescription drugs in short supply or unavailable nationwide, and regulators and manufacturers say shortages are a long-term problem that will continue to give patients and doctors nightmares.

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Yesterday, the Food and Drug Administration said it will temporarily allow import of a replacement drug for Doxil, a drug for recurrent ovarian or bone marrow cancer. The Johnson & Johnson drug has not been available for new patients for months because the company’s contract manufacturer had to shut down production over quality lapses.

The FDA also has approved a new supplier for a preservative-free version of methotrexate, a crucial drug for children with a type of leukemia called ALL, for lymphomas, and for the bone cancer osteosarcoma. The version with preservatives, the one that has been scarce, can be toxic or cause paralysis in patients by injections into spinal cord fluid or at very high doses.

The FDA also has approved the release of a batch manufactured by Ben Venue Laboratories Inc., shortly before it closed several factories at its complex in Bedford, Ohio, due to serious quality problems. That closing was what turned the periodic methotrexate shortage that began in late 2008 into a crisis almost overnight, with fears that children would begin missing treatments within weeks.

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