ARTICLE | Company News
FDA rebuffs NDA for Abilify with Proteus' sensor
April 28, 2016 1:12 AM UTC
FDA issued a complete response letter for an NDA from Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) seeking approval of its Digital Medicine combination product, which includes Otsuka's antipsychotic Abilify aripiprazole and an ingestible digital sensor from Proteus Digital Health Inc. (Redwood City, Calif.).
The partners said they sought approval of a system that measures drug adherence to treat schizophrenia, bipolar disorder and major depressive disorder (MDD). Proteus' computer-enabled ingestible sensor system can deliver real-time monitoring of oral medication outcomes (see BioCentury, Aug. 11, 2014). ...