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www.fdanews.com/articles/175882-fda-issues-complete-response-letter-to-eagles-kangio
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FDA Issues Complete Response Letter to Eagle’s Kangio

March 24, 2016

The FDA put a damper on Eagle Pharmaceuticals’ plans to market its blood thinner Kangio via a complete response letter not recommending approval.

The letter called for a better description of the bivalirudin-related substances in the drugmaker’s 505(b)(2) new drug application.

The Woodcliff Lake, N.J.-based company had been seeking approval for the 5-mg/mL formulation as an anticoagulent for patients undergoing certain heart procedures who also are taking aspirin. It is a ready to use version of The Medicines Company’s Angiomax that does not need to be reconstituted.