Teva Pharma receives US FDA approval for generic Sabril

Teva’s generic Sabril(vigabatrin) tablets are part of a single shared-system Risk Evaluation and Mitigation Strategy (REMS) program.

U.S: The U.S. Food and Drug Administration has recently approved Teva Pharmaceutical Industries Ltd’s first generic version of Sabril (vigabatrin) 500 mg tablets. The drug is used for treating complex partial seizures, also called focal 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.

"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, M.D.

“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."

Complex partial seizures, a common type of seizures, start in a specific area of the brain and can affect consciousness. Typically, complex partial seizures last between 30 and 90 seconds and are often followed by a period of disorientation, confusion and/or fatigue.

Labelling 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 (REMS) program with other drug products containing vigabatrin to ensure the safe use of the product.

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