FDA Clears First Generic Version of Seizure Drug Sabril (Vigabatrin)

Megan Brooks


January 16, 2019

The US Food and Drug Administration (FDA) has approved the first generic version of the antiseizure medication Sabril (vigabatrin, Lundbeck).

Generic vigabatrin (500-mg tablets), made by Teva Pharmaceuticals USA, is indicated as add-on therapy for the treatment of complex partial seizures in patients aged 10 years and older whose condition is refractory to several other treatments.

"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," FDA Commissioner Scott Gottlieb, MD, said in a news release.

"The availability of high-quality generic alternatives of critically important medicines, once the period of patent protection or exclusivity has ended on the brand drug, helps advance access and saves consumers billions of dollars each year," said Gottlieb.

Complex partial seizures, also called focal seizures, are a common type of seizure that typically last from 30 to 90 seconds and are often followed by a period of disorientation, confusion, and/or fatigue, the FDA noted in the release.

The most common side effects associated with vigabatrin tablets include dizziness, fatigue, sleepiness, involuntary eye movement, tremor, blurred vision, memory impairment, weight gain, arthralgia, upper respiratory tract infection, aggression, double vision, abnormal coordination, and a confused state. Serious side effects associated with vigabatrin tablets include permanent vision loss and risk for suicidal thoughts or actions.

Labeling for vigabatrin tablets includes a boxed warning for permanent vision loss. Teva's 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, the FDA said.

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