Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd, said the Food and Drug Administration (FDA) has accepted supplemental New Drug Application (sNDA) for Aciphex for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in patients aged 12-16.
Further, FDA has indicated that the sNDA will receive priority review in accordance with the Best Pharmaceuticals for Children Act, which provides for a 180-day review period.
Aciphex was discovered and developed by Eisai and is copromoted in the United States with PriCara, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Aciphex is a prescription medication. One ACIPHEX 20 mg tablet daily is used in adults for the treatment of persistent, frequent (2 or more days a week) heartburn and other symptoms associated with acid reflux disease.
Aciphex is also used in adults for the short-term (4 to 8 weeks) treatment in the healing and symptom relief of damaging (erosive) acid reflux disease (gastroesophageal reflux disease).