FDA priority review for Eisai's Aciphex

Japanese drug major Eisai says that the US Food and Drug Administration has accepted an Aciphex (rabeprazole sodium) supplemental New Drug Application for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease in patients aged 12-16. Furthermore, the 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 co-promoted in the USA with PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals, a Johnson & Johnson company.