Baxter International, the maker of the blood thinner heparin, says it’s encountering problems having its drug pass a stricter drug-potency test, according to the magazine Modern Healthcare. http://www.modernhealthcare.com/article/20100315/NEWS/303159895
The update that has Baxter troubled has been devised by U.S. Pharmacopeia (USP), and provides potency reading for heparin that are 10 percent greater than the old test.
“It’s taking us a bit longer than anticipated to meet the requirements of the new test,” Baxter spokeswoman Kellie Hotz told Modern Healthcare.
She added that Baxter has been talking to the Food and Drug Administration about way it can meet the new USP standard.
The heparin that is currently being testing is pre-mixed product, not the concentrated vial product that was investigated by the FDA last year, Hotz told Modern Healthcare.
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