Drugs

Spotlight on CDER Science

Spotlight on CDER Science

In Pursuit of Tardive Dyskinesia: The Breakthrough Designation and Approval of Valbenazine

Brian J. Miller, M.D., M.B.A., M.P.H., Michael C. Davis, M.D., Ph.D., and Mitchell V. Mathis, M.D., Division of Psychiatry Products, Office of New Drugs, Center for Drug Evaluation and Research

Diseases that are caused by medical treatments and procedures are a particular bane to health care providers. One such example is tardive dyskinesia, a side effect of taking antipsychotic medicines. Tardive dyskinesia is a neurological disorder characterized by repetitive, involuntary movements such as lip smacking or pursing, as well as tongue movements. Tardive dyskinesia significantly impacts the health and quality of life of many people who live with psychiatric illnesses, and the disorder is often irreversible. The FDA approval of valbenazine this year, the first drug to be indicated for tardive dyskinesia, is therefore noteworthy—not only because it addresses an unmet need, but also because of how it was approved.

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Page Last Updated: 09/20/2017
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