Home » FDA Issues Complete Response Letter to Eagle’s Kangio
FDA Issues Complete Response Letter to Eagle’s Kangio
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.
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