FDA Approves Generic Drug for Epilepsy
The US Food and Drug Administration (FDA) has approved the first generic version of vigabatrin (Sabril), 500 mg, for the treatment of complex partial seizures. The drug is to be used as an adjunctive therapy in individuals aged 10 years or older who have not responded well to other alternative treatments.
The approval for the generic vigabatrin tablets comes after the drug was tested and proven to be as safe and effective as the brand name counterpart. The FDA also inspected the new drug’s manufacturing and packaging facilities to ensure its production is consistently of the same quality.
Vigabatrin is used as an adjunctive therapy in the treatment of complex partial seizures, or focal seizures, which last between 30 and 90 seconds and are often followed by a period of disorientation, confusion, and/or fatigue.
Common side effects for the vigabatrin tablets include dizziness, fatigue, blurred vision, and weight gain.
Serious side effects include permanent vision loss and thoughts of suicide. However, vigabatrin was approved using the risk evaluation and mitigation strategy, meaning it has been deemed that vigabatrin’s benefits outweigh its risks.
According to FDA Commissioner Dr Scott Gottlieb, the approval of the vigabatrin generic is another step toward the FDA supporting access to and reducing drug costs for patients.
“Today’s action demonstrates that there is an open pathway to approving products like this one,” Gottlieb said in an FDA press release. “We know it’s not enough just to approve a record number of generic medicines. We also want to see firms launch these products so that patients can benefit from their availability, and we intend to take steps to advance these goals.”
FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy [press release]. Silver Spring, MD: US Food & Drug Administration; January 16, 2019. . Accessed January 16, 2019.