FDA Declines to Approve Ready-To-Use Drug to Prevent Blood Clots

Originally published by Robert Kraft.

Reuters reported that the Food and Drug Administration has declined to approve Eagle Pharmaceutical Inc.’s Kangio (bivalirudin), a ready-to-use version of Angiomax (bivalirudin), a drug to prevent blood clots among patients undergoing heart surgery. Unlike Angiomax, Kangio did not need to be reconstituted with water and diluted before use. The FDA declined Kangio’s application in its current form and requested additional information from the drugmaker. The Bergen (NJ) Record also covered the story.

From the news release of the American Association for Justice.

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