FDA Approves First Digital Pill: Otsuka/Proteus' Abilify MyCite

Otsuka plans a slow, measured launch of Abilify MyCite, developed with Proteus Health. The product includes an ingested sensor that sends a signal to a wearable patch and an app that tracks ingestion, activity and mood to potentially improve management of psychiatric care.

Women hand holding smartphone and using Twitter application

Abilify MyCite (aripiprazole tablets with sensor) passed its first big test with US FDA approval of the digital atypical antipsychotic, but with a slow launch by Otsuka Pharmaceutical Co. Ltd. it may take a while for the product to receive passing grades from patients, doctors and payers.

Otsuka and partner Proteus Digital Health Inc. initially failed to win FDA approval in April 2016 for their digital...

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