The agency says the digitally enhanced medication "works by sending a message from the pill's sensor to a wearable patch".
The prescribing notes also stress that Abilify MyCite should not be used to track drug ingestion in "real-time" or during an emergency, because detection may be delayed or may not occur. Patients can allow their caregivers and physician to access the information through a web-based portal.
The drug Abilify MyCite was developed by Otsuka Pharmaceutical Co., Ltd. Abilify was first approved by the FDA in 2002 to treat schizophrenia, and the ingestible sensor, made by Proteus Digital health, was initially approved for marketing in 2012.
Dr Mitchell Mathis, who is director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said: "Being able to track ingestion of medications prescribed for mental illness may be useful for some patients".
But the digital pill hasn't yet been approved for use here.
"However, we will need to be convinced that the overall therapeutic and costs benefits of the medication tracker make it worthwhile", she said.
The pills are not licensed to be used in elderly patients with dementia-related psychosis.
Andrew Thompson, president and CEO at Proteus Digital Health, said: "The time is right for the category of Digital Medicines to be available to appropriate patients with serious mental illness".
"Consumers already manage important tasks like banking, shopping, and communicating with friends and family by using their smart phones, as they go about their daily lives".
"This technology can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way".