FDA approves first generic version of epilepsy drug Sabril from Teva

The US Food and Drug Administration (FDA) approved the first generic version of Sabril (vigabatrin) Tablets manufactured by Teva Pharmaceutical Industries (NYSE: TEVA) US subsidiary, for treating complex partial seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments.

This approval helps to provide a safe, effective, quality, and affordable treatment option for certain patients, the agency stated.

"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. 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 FDA Commissioner Scott Gottlieb.