FDA approves first generic version of vigabatrin

FDA has approved the first generic version of the anti-seizure medication vigabatrin (Sabril—Lundbeck).

FDA has approved the first generic version of the anti-seizure medication vigabatrin (Sabril—Lundbeck). Made by Teva Pharmaceuticals, generic vigabatrin, in 500 mg tablets, was approved for the treatment of complex partial seizures as an adjunctive therapy in patients aged 10 years and older who have responded inadequately to several refractory treatments. FDA Commissioner Scott Gottlieb, MD, noted: "Today's action demonstrates that there is an open pathway to approving products like this one. We're especially focused on new policies aimed at making the generic review process more predictable, efficient, and lower cost so we can entice more generic firms to enter this space, and help facilitate more generic drug launches after generic approvals." Labeling for vigabatrin features a boxed warning about permanent vision loss. The generic vigabatrin tablets are part of a single shared-system Risk Evaluation and Mitigation Strategy program with other drug products containing vigabatrin to ensure safe use of the product. Common adverse events associated with vigabatrin tablets include dizziness, fatigue, sleepiness, involuntary eye movement, tremor, blurred vision, memory impairment, weight gain, joint pain, upper respiratory tract infection, aggression, double vision, abnormal coordination, and a confused state. Serious adverse events linked to the drug include permanent vision loss and risk of suicidal thoughts or actions.