FDA Granted A Priority Review To Abilify(R) (Aripiprazole) Supplemental New Drug Application
Abilify (Aripiprazole) is considered to be an effective antipsychotic medication for treating schizophrenia disease and Bipolar I Disorder. The drug is developed by two partnered companies: Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company.
They announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) of Abilify drug for filing. Besides, FDA granted a Priority Review to sNDA for the treatment of pediatric patients (10 to 17 years old) suffer from Bipolar I Disorder, manic or mixed episode with or without psychotic features.
In order to inspect this sNDA the specialists have conducted a randomized, multicenter, double-blind, placebo-controlled study. Sponsored by Otsuka Pharmaceutical Co., Ltd. the study evaluated the efficacy and safety of two fixed oral doses of Abilify 10 mg a day and 30 mg/day. The trial lasted 30 weeks and included 296 ethnically diverse pediatric patients (ages 10 to 17) with Bipolar I Disorder.
Obtained data made it possible to receive a Priority Review status for a supplement for Aripiprazole tablets.
