FDA approves first pill with digital ingestion tracking system

The FDA approved the first drug in the U.S. Monday that can track medication ingestion and alert a patient's physician or caregiver when it is taken.

The drug, Abilify MyCite, has an ingestible sensor embedded into the pill to record when the medication was taken. When the pill is swallowed, the sensor sends a message to a wearable patch, which then transmits information to a mobile app so patients can monitor their medication intake on their phones. Patients can also allow their caregivers and physicians to access the data from the app through an online portal.

Abilify MyCite, manufactured by Otsuka Pharmaceutical Co., is approved for schizophrenia, acute bipolar disorder and adult depression. The sensor technology and patch are made by Proteus Digital Health.

The FDA noted that the drug should not be used to track ingestion in real time, since detection may be delayed.



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