FDA NDA

By  Jonah Comstock 05:23 pm May 23, 2017
One year after the FDA declined to approve Proteus Digital Health and Otsuka's new sensor-embedded formulation of Otsuka's antipsychotic drug Abilify, the companies are giving it another shot, resubmitting the application with additional information. As before, the application is a New Drug Application (NDA) -- both the Proteus system itself and Abilify are already FDA cleared and approved,...