Eisai announces FDA acceptance of AcipHex NDA for priority review
Published on November 30, 2012 at 10:52 AM
Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review Eisai's New Drug Application (NDA) for AcipHex® Delayed-Release Sprinkle Capsules 5mg and 10mg for the proposed indication of healing of Gastroesophageal Reflux Disease (GERD), maintenance of healing of GERD and improvement of symptoms of GERD in children 1 to 11 years of age.
Acceptance of the NDA indicates that the FDA has found the company's submission to be sufficiently complete to review. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of March 27, 2013.