Pharmaceutical Business review

FDA to review Eisai’s Aciphex sNDA

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.