FDA Accepts First Digital Medicine New Drug Application For Otsuka & Proteus Digital Health

Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health announced that the U.S. Food and Drug Administration (FDA) has determined that the New Drug Application (NDA) for the combination product of ABILIFY (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet is sufficiently complete to allow for a substantive review and is considered filed as of September 8, 2015. The ABILIFY tablet contains an ingestible sensor that communicates with a wearable sensor patch and a medical software application for measuring adherence in the treatment of adults with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar . . .