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Digital Age: Otsuka Sets Sights On Abilify Combo Tablet With Sensor

 
• By Jessica Merrill

First-of-its-kind NDA is for a combination product of Abilify embedded with an ingestible sensor to measure adherence and physiologic response. Otsuka sees opportunities to extend brand facing generic competition and for combo approach with future medicines too.

Otsuka Pharmaceutical Co. Ltd. has set its sights on a new digital tablet of Abilify (aripiprazole) to extend the life of the brand that is now facing generic competition. The company announced Sept. 10 that a combination of the atypical antipsychotic embedded with an ingestible sensor developed by partner Proteus Digital Health Inc. has been accepted for filing by FDA. The PDUFA date is in April 2016.

The combination represents the first time such a pill has been submitted to FDA for review, according to the company....

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