DUBLIN, March 11, 2019 /PRNewswire/ — Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Ne
Source: www.prnewswire.com
The U.S. Food and Drug Administration (FDA) has accepted Allergan plc’s (NYSE: AGN) New Drug Application (NDA) for ubrogepant. Ubrogepant is a CGRP receptor antagonist in development for the acute treatment of migraines. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. The NDA is based on the successful completion of four clinical trials – two pivotal studies, ACHIEVE I and ACHIEVE II and two additional safety studies UBR-MD-04 and 3110-105-002. A 10-month review period has been assigned to the Prescription Drug User Fee Act (PDUFA) in the fourth quarter of 2019.
