FIRST FDA APPROVED DIGITAL MEDICINE – BRIEF NOTE
ABOUT AUTHOR
Rajesh S Vagh
PharmaTutor Edu Labs,
Surat, Gujarat, India
rajesh@pharmatutor.org
Last year in November, FDA had approved first DIGITAL MEDICINE, ABILIFY MYCITE which is a drug-device combination product comprised of Otsuka's oral aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor. In simple word, it is an aripiprazole tablet with sensor. It is indicated in adults for the treatment of schizophrenia, bipolar I disorder, acute treatment of manic and mixed episodes as monotherapy and as adjunct to lithium or valproate, maintenance treatment as monotherapy and as adjunct to lithium or valproate and adjunctive treatment of major depressive disorder.
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