Regulatory Roundup: Three Companies Working With FDA to Restore Depleted US Supplies of the Leukemia Drug Cytarabine
FDA Released Draft Guidance for Industry on Safety Labeling Changes.
According to Bloomberg News, Hospira, Fresenius SE, and Boehringer Ingelheim GmbH are working with FDA to restore depleted US supplies of the leukemia drug cytarabine. FDA has reportedly found an offshore manufacturer of the product to temporarily import the injectable product while other manufacturers work to increase their production levels of the product to meet patient demand. There have been problems with obtaining the drug's primary ingredient and preventing crystals of dried medicine from forming in vials, according to the Bloomberg report.
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