Posted by Michael Wonder on 16 Apr 2018
Eagle Pharmaceuticals’ vasopressin ANDA accepted for filing by the FDA
16 April 2018 - Eagle Pharmaceuticals today announced that it has submitted and the U.S. FDA has accepted for filing its abbreviated new drug application for vasopressin injection.
This product is the generic version of Endo International plc’s original Vasostrict formulation, which is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.
Vasostrict had approximately $400 million in brand sales in 2017.
