First-Ever Generic Abilify Gets FDA Go-Ahead

Aripiprazole, generic Abilify, approved to treat bipolar disorder and schizophrenia by FDA

(RxWiki News) Four pharmaceutical companies received approval today from the US Food and Drug Administration (FDA) to market generic versions of Abilify, an atypical antipsychotic drug.

Teva Pharmaceuticals, Alembic Pharmaceuticals Ltd., Hetero Labs Ltd. and Torrent Pharmaceuticals Ltd. received approval to market aripiprazole to treat bipolar disorder and schizophrenia.

“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.”

Bill Swail, RPh, founder of Peoples Rx in Austin, TX, told dailyRx News that the generic drugs are likely to be as effective as the brand name medication.

"They're also likely to be cheaper by 10 percent or more," Swail said.

"Everyone should be concerned about the cost of medications and health care overall," he said. "Pharmacists can play their part by encouraging the use of generics."

Aripiprazole received the FDA's approval after testing for safety and effectiveness. Common side effects include vomiting, nausea, headache, constipation, anxiety, dizziness and insomnia.

Aripiprazole, like other atypical antipsychotic medications, will contain a boxed warning that notes a raised death risk if the drug is used to treat older patients with psychosis related to dementia — which this drug is not approved to do. An additional boxed warning for aripiprazole will note a raised risk of suicidal thoughts and actions in young people who take this drug.

Schizophrenia and bipolar disorder — the two conditions aripiprazole was approved to treat — are both serious mental health conditions. Bipolar disorder is marked by symptoms like sudden mood, energy and activity shifts. Schizophrenia patients are often suspicious of others and have auditory hallucinations.

Review Date: 
April 28, 2015