FDA Accepts for Filing Eagle Pharmaceuticals ANDA for Vasopressin
18 April 2018 - - US-based specialty pharmaceutical company Eagle Pharmaceuticals, Inc. (NASDAQ: EGRX) has submitted, and the US Food and Drug Administration has accepted for filing, its abbreviated new drug application (ANDA) for vasopressin injection, 1ml, the company said.
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 USD 400m in brand sales in 2017.
Eagle is focused on developing and commercializing injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. Eagle's strategy is to utilize the FDA's 505(b) (2) regulatory pathway.