FDA approves generic version of Abilify® to treat mental illness

The FDA announced that it approved the first generic versions of Abilify® (Aripiprazole), an atypical antipsychotic, to treat schizophrenia and bipolar disorder, both potentially serious brain disorders. Four companies, Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals, and Torrent Pharmaceuticals Ltd., received approval for marketing generic Aripiprazole in multiple strengths and dosages.

The FDA, in announcing the approval, emphasized the importance of access to generic medications and the safety of the drugs. “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.”

Additionally, according to the FDA, generic drugs are required to be identical to the branded drugs in “dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.” They must also be manufactured under the same standards of the FDA’s Good Manufacturing Practice Regulations.

According to the National Institute of Mental Health, schizophrenia is a disabling and serious, chronic brain disorder, the symptoms of which can include a patient hearing voices and having suspicious thoughts. Bipolar disorder, also known as manic-depressive illness, can be accompanied by symptoms such as shifts in mood and energy, alternating between depression and high, irritable moods.

Like all other atypical antipsychotic drugs, Aripiprazole is not approved for use by older patients with dementia-related psychosis, and contains a Boxed Warning alerting health care professionals to the increased risk of death associated with the off-label use of the product in such patients. Additionally, the drug contains a Boxed Warning of the increased risk of suicidal thoughts in children, adolescents, and young adults taking the medication.