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Biotech Stocks Facing FDA Decision In December 2021

Eagle Pharmaceuticals
Eagle Pharmaceuticals

Eagle Pharmaceuticals Inc.’s (EGRX) Abbreviated New Drug Application for Vasopressin is under priority review by the FDA, with a decision expected on December 15.

The company’s Vasopressin references Endo International subsidiary Par Pharmaceutical Inc’s Vasostrict, which is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.

Eagle Pharma is the first to seek approval for a generic version of Vasostrict which had total U.S. sales of $786 million in 2020.

In February of this year, Eagle Pharma’s Vasopressin was turned down by the FDA and this is the product’s second go-around with the regulatory agency.

In May 2018, a patent suit was filed by Par Pharma alleging that Eagle Pharma’s Vasopressin infringed on Vasostrict. However, the suit has gone in favor of Eagle Pharma - with the U.S. District Court for the District of Delaware in August of this year ruling that Eagle’s proposed Vasopressin product does not infringe any of the patents Par asserted against the company.

EGRX closed Friday’s trading at $48.10, down 4.22%.