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FDA Approves First US Digital Medicine System

FDA news release; 2017 Nov 14

The US Food and Drug Administration (FDA) has approved the first drug in the US with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults.

The system works by sending a message from the pill’s sensor to a wearable patch, which transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.

The FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd., headquartered in Tokyo, Japan. The sensor technology and patch are made by Proteus Digital Health, headquartered in Redwood City, CA.

Citation:

FDA approves pill with sensor that digitally tracks if patients have ingested their medication. New tool for patients taking Abilify. [FDA news release]. November 14, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm?utm_campaign=11132017_PR_FDA%20approves%20sensor%20pill%20for%20Abilify&utm_medium=email&utm_source=Eloqua. Accessed December 1, 2017.

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