-- Submission seeks approval for landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter -- --...
WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that AOP Orphan Pharmaceuticals GmbH, Member of the AOP Health Group, (“AOP Health”), with whom it entered into a licensing agreement in August 2021, has engaged with the U.S. Food and Drug Administration (“FDA”) to obtain alignment on the content and format of the pre-clinical and clinical data required to support a new drug application (“NDA”) seeking approval of Landiolol, a novel therapeutic, for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.