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FDA approves generic versions of Abilify for schizophrenia, bipolar disorder
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The FDA today approved generic versions of Abilify for treatment of schizophrenia and bipolar disorder.
FDA approval for marketing multiple strengths and dosage forms of aripiprazole has been granted to Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals.
The boxed warning for aripiprazole indicates children, adolescents and young adults taking antidepressants may have an increased risk for suicidal thinking and behavior.
In clinical trials, the most common side effects reported by adults were nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia and restlessness.
“Having access to treatments is important for patients with long-term health conditions,” John Peters, MD, acting director of the Office of Generic Drugs of the FDA’s Center for Drug Evaluation and Research, said 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.” – by Amanda Oldt