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Abilify Digital Approval Status

  • FDA approved: No
  • Brand name: Abilify Digital
  • Generic name: aripiprazole
  • Company: Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health
  • Treatment for: Schizophrenia, Bipolar Disorder

Abilify Digital (aripiprazole) is a tablet formulation of an approved atypical antipsychotic embedded with an ingestible Proteus® sensor that communicates with a wearable sensor patch and a medical software application in development for measuring adherence in the treatment of adults with schizophrenia, bipolar I disorder, and major depressive disorder.

On April 26, 2016, Otsuka and Proteus announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for their Digital Medicine, a drug/device combination product. The FDA completed its review and has requested additional information, including data regarding the performance of the product under the conditions in which it is likely to be used, and further human factors investigations.

Development Status and FDA Approval Process for Abilify Digital

Apr 26, 2016FDA Issues Complete Response Letter for Digital Medicine New Drug Application
Sep 10, 2015U.S. FDA Accepts First Digital Medicine New Drug Application for Otsuka and Proteus Digital Health

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