Abilify gets agency nod as major depression add-on

November 26, 2007

Aripiprazole approved for depression

Bristol-Myers Squibb and Otsuka Pharmaceuticals have received word from the FDA that aripiprazole (Abilify) has been approved as an adjunctive treatment for adults with major depressive disorder (MDD), marking the second supplemental approval for the drug in one month-aripiprazole was just OK'd as a treatment for schizophrenia in adolescents aged 13 to 17 years. According to the companies, the new MDD approval marks the first time a medication has been approved as an add-on treatment for the illness. This approval was based on two six-week studies that demonstrated significant improvement in depressive symptoms in patients who did not respond well to monotherapy with another antidepressant. Aripiprazole was initially approved as a treatment for schizophrenia in adults in 2002 and is also indicated for acute manic or mixed episodes associated with bipolar 1 disorder.

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