Ajanta has launched aripiprazole tablets in 2.5-mg, 5-mg, 10-mg, 15-mg, 20-mg, and 30-mg doses in the United States. The tablets are a bioequivalent generic version of Abilify, which is trademark-registered by Otsuka Pharmaceutical Co.
The wholly owned subsidiary of Ajanta Pharma Limited received final approval from the FDA for the aripiprazole tablets in September.
Abilify is used to treat symptoms of psychotic conditions, such as schizophrenia, in a wide range of patients. However, it is not known if it is safe or effective in children younger than 13 with schizophrenia or children younger than 10 with bipolar disorder.
The most frequent adverse events associated with Abilify are difficulty speaking, drooling, loss of balance control, muscle trembling, restlessness, and stiffness. Less common adverse events include blurred vision, dizziness, fast heartbeat, high fever, and high or low blood pressure.
In 2009, the FDA also approved Abilify for the treatment of irritability in pediatric patients with autistic disorder between the ages of 6 and 17. The decision was based on results from 2 studies, CN138-178 and CN138-179. In participants, the most commonly reported adverse events included sedation, fatigue, vomiting, and tremors.
Other conditions Abilify has been studied for are bipolar disorder, major depressive disorder, and Tourette’s disorder. In an injectable form, Abilfy may be indicated for the treatment of schizophrenia or bipolar mania.
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