10 September 2015 - Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health today announced that the United States 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.

This is the first time an FDA-approved medication (ABILIFY) has been combined and submitted for approval with a sensor within the medication tablet (the Proteus ingestible sensor) to measure actual medication-taking patterns and physiologic response. This objective information is communicated to the patient - and with the consent of the patient - to the patient’s physician and/or caregiver. Digital Medicines may enable improved patient medication adherence and better informed physician decision-making to tailor treatment to the patient’s needs.

For more details, go to: http://www.businesswire.com/news/home/20150910005497/en/U.S.-FDA-Accepts-Digital-Medicine-Drug-Application#.VfHuurTC1Vs