The FDA has accepted Eagle Pharmaceuticals’ abbreviated new drug application (ANDA) for vasopressin injection, 1ml for filing. 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.
“We are pleased that the FDA has accepted our vasopressin injection formulation for filing. We look forward to the FDA’s decision and intend to work closely with them through the review process,” stated Scott Tarriff, chief executive officer of Eagle Pharmaceuticals.
(Source: Eagle Pharmaceuticals)
Filed Under: Drug Discovery