Tuesday, November 21, 2017

FDA: New suppliers to ease 2 cancer drug shortages

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

On Tuesday, the Food and Drug Administration said it will temporarily allow importation of a replacement for Doxil, a drug for recurrent ovarian or bone marrow cancer. The Johnson & Johnson drug hasn't been available for new patients for months because Johnson & Johnson's contract manufacturer had to shut down production over serious quality lapses.

Sun Pharma Global FZE of India will supply the replacement.

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 children and other patients getting the drug either by injections into spinal cord fluid or at very high doses.

APP Pharmaceuticals LLC will make the preservative-free version of methotrexate.

The FDA had 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 quality problems.

"We have made real progress. … We believe that (suppliers) will be able to meet the demands of patients in the U.S. market" for the two drugs indefinitely, FDA Commissioner Margaret Hamburg told the Associated Press. "It's a huge relief for us."

Many medical and drugmaker groups, along with the White House, applauded the news but cautioned that much still must be done to resolve all the problems causing drug shortages.

There are currently 283 separate 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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