FDA Okays First Aripiprazole Generics

Caroline Cassels


April 28, 2015

The US Food and Drug Administration (FDA) has approved the first generic versions of the atypical antipsychotic aripiprazole (Abilify, Otsuka Pharmaceutical Co, Ltd) for the treatment of schizophrenia and bipolar disorder.

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

All atypical antipsychotics contain a boxed warning alerting healthcare professionals about an increased risk for death associated with the off-label use of these drugs to treat behavioral 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 includes a warning about an increased risk for suicidality in children, adolescents, and young adults taking antidepressants.

Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors. Aripiprazole must be dispensed with a patient medication guide that describes important information about the drug's uses and risks.

The most common reported side effects associated with aripiprazole in adults are nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness.

According to the FDA, approved generic medications have the same high quality and strength as brand-name drugs. Generic prescription drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs, the agency notes.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.