The Food and Drug Administration (FDA) has approved Teva’s generic version of Sabril (vigabatrin; Lundbeck) tablets for the treatment of refractory complex partial seizures (focal seizures) as adjunctive therapy in patients ≥10 years of age who have responded inadequately to several alternative treatments; it is not indicated as a first line agent.
“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,” said FDA Commissioner Scott Gottlieb, MD. “We know there has been past interest in developing a generic alternative to this product.”
As treatment with vigabatrin may be associated with permanent vision loss, the generic tablets are also part of a single shared-system Risk Evaluation and Mitigation Strategy (REMS) program to ensure the product is used safely.
Vigabatrin Tablets will be available in a 500mg dosage strength.
For more information visit FDA.gov.