Eisai announces FDA acceptance of AcipHex NDA for priority review

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Eisai Inc.Nov 30 2012

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.

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Posted in: Child Health News | Pharmaceutical News

Tags: Abdominal Pain, Acid Reflux, Antibody, Atazanavir, Children, Clostridium Difficile, Constipation, Diarrhea, Fever, Food, Gastroesophageal Reflux Disease, Headache, Heartburn, Methotrexate, Muscle, Nausea, Neuroscience, New Drug Application, Oncology, Pain, Prescription Drug, Sore Throat, Spine, Vomiting, Warfarin

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