Generics
The US FDA authorises the first generic Sabril for the treatment of complex partial seizures in adults and pediatric patients
17 January 2019 -

Public health agency The US Food and Drug Administration on Monday announced the approval of the first generic version of Sabril (vigabatrin) in 500mg tablets for treating complex partial seizures, also called focal seizures, in patients ten years and older.

This US FDA's approval of generic vigabatrin tablets was granted to Teva Pharmaceuticals USA.

The agency has approved the first generic version of Sabril (vigabatrin) in 500mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients ten years and older who have responded inadequately to several alternative (refractory) treatments.

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.

Teva's generic vigabatrin tablets is part of a single shared-system Risk Evaluation and Mitigation Strategy (REMS) programme with other drug products containing vigabatrin to ensure safe use of the product under the US FDA's requirement.

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