(Source: Otsuka America Pharmaceutical Inc) Tokyo, Japan, and Redwood City, Calif. - April 26, 2016 -Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital Health (Proteus) today announced that the United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for their Digital Medicine, a drug/device combination product, which combines Otsuka's ABILIFY (aripiprazole), an atypical antipsychotic, with the FDA-cleared Proteus ingestible sensor embedded in a single tablet at point of manufacture. The NDA was submitted for an indication to measure medication adherence to aripiprazole in adults as a treatment for schizophrenia, as an acute treatment of manic...
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