Three Indian pharmaceutical companies, namely Alembic Pharmaceuticals, Hetero Labs and Torrent Pharmaceuticals have received the US Food and Drug Administration (FDA) approval for generic versions of Abilify (aripiprazole), an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder.   Teva Pharmaceuticals has also received similar approval.

“Having access to treatments is important for patients with long-term health conditions,” said John Peters, MD, acting director of the Office of Generic Drugs in the FDA’s Centre 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 per cent of Americans have this illness. Typically, symptoms are first seen in adults younger than 30 years of age. Symptoms of schizophrenia include hearing voices, believing other people are reading their minds or controlling thoughts and being suspicious or withdrawn.

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. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.

All atypical antipsychotics contain a boxed warning alerting health care professionals about an increased risk of death associated with the off-label use of these drugs to treat behavioural problems in older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis.

Aripiprazole’s boxed warning also warns about an increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.

In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness.