FDA takes another look at cancer drug shortage
April 19th, 2011 // 1:19 pm @ jmpickett
FDA is brokering a deal to keep supplies of a leukemia drug available to U.S. patients. It’s been working with Hospira, APP Pharmaceuticals and the Bedford Labs division of Boehringer Ingelheim, producers of the FDA-approved cytarabine that have been hamstrung in producing the parenteral due to scarcity of API. In addition, some supplies of finished product haven’t made it to patients due to crystals found in vials, an issue that has since been resolved.
But the FDA, which began looking for a backup supplier as the cytarabine shortage worsened earlier this year, has located an overseas drugmaker that will temporarily import the injections, reports Bloomberg. That drugmaker’s cytarabine product is unapproved by the agency, however.
As the import deal comes together, the usual suppliers are close to resuming shipments. APP expects to distribute vials next week, while Bedford Labs plans to release 82,000 vials in the next few weeks, the story says. Hospira, which is shipping the drug, projects it will be able to boost supplies “in the coming weeks and months.”
The FDA recently was involved in an effort to boost the dwindling supply of another cancer drug, leucovorin. The regulator worked with supplier Spectrum Pharmaceuticals and gave the OK to import the drug.
Read more: FDA takes another look at cancer drug shortage – FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-takes-another-look-cancer-drug-shortage/2011-04-19#ixzz1JyUvUwRj
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