January 21, 2019—The Food and Drug Administration (FDA) has approved generic vigabatrin 500 mg tablets for adjunctive treatment of patients with complex partial seizures, age 10 years and older, who have not responded adequately to other treatments.
“We know there has been past interest in developing a generic alternative to this product,” said Scott Gottlieb, MD, FDA commissioner. “Earlier this year, we also highlighted this drug, along with many others, on a list of off-patent, off-exclusivity branded drugs without approved generics, to clarify that there were no patents or exclusivities that should impede its approval. Prioritizing the approval of generic drugs to compete with medicines that face little or no competition is a key part of our efforts to support access and reduce drug costs to patients.”
Because generic vigabatrin includes a boxed warning for permanent vision loss, the drug is part of a single shared-system Risk Evaluation and Mitigation Strategy (REMS) program with other drugs containing vigabatrin to ensure that they are used safely.
Chengyuan Wu, MD, MSBmE
Kevin J. Felice, DO
Arnold M. Salazar; Amanda M. Leisgang; Andrew A. Ortiz; and Jefferson W. Kinney, PhD