Antipsychotic Agent Gets First Generic Approval

The Food and Drug Administration (FDA) has approved Aripiprazole, the first generic version of Otsuka's Abilify.

Abilify is an atypical antipsychotic currently approved for multiple psychiatric disorders, including acute and maintenance treatment of manic or mixed episodes in bipolar disorder as monotherapy; or as an adjunct to lithium or valproate; as adjunct to antidepressants for major depressive disorder; irritability associated with autistic disorder; schizophrenia, and others.

RELATED: Some Abilify Formulations to Discontinue in 2015

The efficacy of Abilify may be mediated through a combination of partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors. Actions at receptors other than D2, 5-HT1A, and 5-HT2A may explain some of its other clinical effects.

Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals, and Torrent Pharmaceuticals have received approval to market Aripiprazole in various strengths and dosage forms.

For more information call (888) 463-6332 or visit FDA.gov.

Loading links....