ABILIFY (Aripiprazole) In Treatment Of Depression Disorder
ABILIFY (Aripiprazole) drug was developed by two companies: Otsuka Pharmaceutical Co., Ltd and Bristol-Myers Squibb Company. In 2004 Abilify medicine was approved in for treating schizophrenia disease and in 2008 it was ratified as medicine for bipolar disorder.
It has been known today that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted a Priority Review for the supplemental New Drug Application (sNDA) of ABILIFY tablets. As a rule, an application or supplement for a drug product must meet some requirements to get Priority Review status. Firstly, it must have an approval of the FDA. Secondly, it has to be a significant improvement, compared to marketed products, including non-drug products/therapies. And usually it takes six months for The FDA to review a drug with Priority Review.
Aripiprazole medication was proved to be effective for the treatment of adults with major depressive disorder as adjunctive to antidepressant therapy (ADT). There were conducted two double-blind, randomized, placebo-controlled, multi-center studies including adult patients with a primary diagnosis of major depressive disorder who had an inadequate response to monotherapy with one or more ADTs. After six week the studies demonstrated positive results on which sNDA is based.
