Posted from: Thursday, February 07, 2019 - 05:35 PM - Present

New Generic Approved for Sabril

January 16, 2019 – The U.S. FDA has approved Teva Pharmaceuticals’ generic version of Lundbeck’s Sabril® (vigabatrin) 500mg tablets. The tablets are indicated as an adjunctive therapy for the treatment of complex partial seizures in patients at least 10 years of age who have not had an adequate response to other treatments.

Also known as focal seizures, complex partial seizures are the most common type of seizure affecting adults who have epilepsy. They begin in one area or side of the brain, and can last for a few minutes at a time. During the seizure, patients may experience symptoms that include involuntary motions and impaired awareness of their surroundings. They may also feel fatigued and disoriented following the seizure. Recovery times can vary depending on the exact nature of the seizure.

A black box warning cautions that vigabatrin can cause permanent vision loss, with the risk of vision loss increasing at higher doses and with cumulative exposure. Recommended dosing is based on age, weight, and dosage form. A 500mg oral solution generic for Sabril has been available from Amneal Pharmaceuticals since 2018. Both the oral solution and tablets are available only through a Risk Evaluation and Mitigation Strategy.

Teva has launched its generic vigabatrin tablets at an average wholesale price (AWP) of $15,156.85 per 100-tablet bottle. Brand name Sabril is available at an AWP of $17,534.08 for the same quantity.

Last Updated Thursday, April 18, 2019 - 09:56 AM.