The FDA approved the first generic version of Sabril (vigabatrin) tablets, giving a thumbs up to Teva’s 500 mg vigabatrin tablets for treating complex partial seizures, also known as focal seizures.
The agency approved vigabatrin as an adjunctive therapy for patients ten years and older who haven’t responded adequately to certain alternative treatments. The product comes with a boxed warning for permanent vision loss. Side effects include dizziness, fatigue, blurred vision, memory impairment and double vision.
FDA Commissioner Scott Gottlieb said the approval “demonstrates that there is an open pathway” for such products.