FDA Approves First Generic to Treat Schizophrenia, Bipolar Disorder

The FDA today approved the first generic versions of aripiprazole (Abilify) to treat schizophrenia and bipolar disorder.

The approval allows Alembic Pharmaceuticals Ltd, Hetero Labs Ltd, Teva Pharmaceuticals, and Torrent Pharmaceuticals Ltd, to market the medication in various strengths and dosages.

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

The most common adverse side effects for the medication include nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements, anxiety, insomnia, and restlessness.

The Boxed Warning for aripiprazole notes an increased risk of suicidal thinking and behavior among youths taking antidepressants. The warning for aripiprazole also cautions that older patients with dementia-related psychosis may face an increased risk of death.

Roughly 1% of Americans have schizophrenia, a condition that can cause patients to hear voices, be suspicious or withdrawn, or believe other people are reading their minds, among other symptoms.

Bipolar disorder may cause patients to experience phases of depression and high or irritable mood, plus racing thoughts and impulsive behavior.