US FDA rejects application for Eagle Pharma’s blood thinner; shares plunge
pharmafile | March 21, 2016 | News story | Research and Development, Sales and Marketing | Eagle Pharmaceuticals, Kangio, US FDA, blood thinner
Shares in Eagle Pharmaceuticals (Nasdaq: EGRX) closed down almost 19% Friday after the US Food and Drug Administration rejected the company’s application for its blood thinner for patients undergoing percutaneous heart surgery.
The regulator did not approve the application in its present form asked for additional information, the company said in a statement.
The drug, Kangio (bivalirudin injection) is a ready-to-use version of Angiomax.
Scott Tarriff, chief executive of Eagle Pharma says: “We are evaluating the FDA’s response and will work closely with the agency to better understand and address their comments regarding Kangio. We remain committed to Kangio as an important new formulation of bivalirudin for intravenous use, offering multiple benefits for patients and care givers.”
Shares in the company closed down nearly 19% to $43.50 on the Nasdaq Friday.
Anjali Shukla
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