FDA approves first generic versions of Abilify

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced approval for the first generic versions of Abilify (aripiprazole) tablets, an antipsychotic drug indicated for the treatment of schizophrenia and bipolar disorder.

 

The following companies been granted approval by the FDA to market generic aripiprazole: Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals. 

 

“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.”

 

About one percent of Americans have schizophrenia, the FDA said. Symptoms first appear in adults younger than 30 years of age and include “hearing voices, believing other people are reading their minds or controlling thoughts and being suspicious or withdrawn.”



Bipolar disorder — also referred to as manic-depressive illness — causes shifts in mood, energy and activity levels and can affect a person’s ability to perform daily tasks, the FDA stated. Symptoms can include periods of depression, increased activity and restlessness and impulsive behavior, among others.