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FDA Approves Abilify for Major Depressive Disorder

www.efluxmedia.com

The U.S. Food and Drug Administration approved the supplemental New Drug Application for Abilify (aripiprazole) as adjunctive, or add-on treatment to antidepressant therapy (ADT) in adults with major depressive disorder (MDD).

The drug was originally approved in 2002 for schizophrenia, as well as mixed episodes in adults suffering from bipolar I disorder. Abilify is the first drug approved by the FDA as add-on treatment for MDD, according to Bristol-Myers Squibb, which revealed the FDA decision. Both Bristol and Otsuka Pharmaceutical Co LTD of Japan sell the drug.

"The approval of this new add-on treatment option is critical for adults suffering from depression who cannot find sufficient relief for their symptoms with antidepressants alone. Now physicians have a proven new option they can add to their patients' antidepressant treatments to help them feel better and relieve unresolved depressive symptoms," said Madhukar Trivedi, M.D., Professor and Chief- Division of Mood Disorders, University of Texas Southwestern Medical School, Dallas, Texas.

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