FDA Approves Generic Abilify: Teva, Alembic, Hetero, Torrent Come to Market

April 28, 2015

FDA has approved the first generic versions of Abilify (aripiprazole). Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder.

Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic aripiprazole in multiple strengths and dosage forms.

“Having access to treatments is important for patients with long-term health conditions,” said John Peters, M.D., acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Health care professionals and consumers can be assured that FDA-approved generic drugs have met the same rigorous standards as the brand-name drug.”

Schizophrenia is a chronic, severe and disabling brain disorder. About one percent of Americans have this illness. Typically, symptoms are first seen in adults younger than 30 years of age.

Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks.

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