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news.Eisai has said that the FDA has accepted an Aciphex supplemental new drug application or sNDA for the short-term treatment of gastroesophageal reflux disease in patients aged 12-16.
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The FDA has also 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 co-promoted in the US with PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals.