FDA approves first generic Abilify

FDA approved the first generic versions of Abilify (aripiprazole), an antipsychotic drug approved to treat schizophrenia and bipolar disorder, on April 28.

Abilify is manufactured by Otsuka.

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

“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 Center for Drug Evaluation and Research, 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.”

Related:First atypical antipsychotic approved for pediatric patients with bipolar I disorder in five years

All atypical antipsychotics contain a Boxed Warning alerting healthcare professionals about an increased risk of 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.

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Aripiprazole’s Boxed Warning also warns about an increased risk of suicidal thinking and behavior 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.

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.

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