FDA OKs Generic Vigabatrin Tablets for Seizures

Officials with the FDA today approved the first generic version of vigabatrin 500-mg tablets, which is also sold under the brand name Sabril, a medication used to treat complex partial seizures, according to a press release.

Complex partial seizures, also called focal seizures, is a common type of seizure that begins in a specific area of the brain and can affect consciousness. Vigabatrin is indicated as an adjunctive therapy for focal seizures in patients 10 years of age and older who have responded inadequately to several alternative treatments.

Sabril, which is marketed by Lundbeck, was approved by the FDA in 2009 in tablet and powder form. The medication includes a boxed warning for the possibility of permanent vision loss. The label also includes warnings for suicidal behavior and ideation, anemia, and abnormal MRI changes, according to the prescribing information. Teva’s generic version is part of a single shared-system risk evaluation and mitigation strategy program with other drug products containing vigabatrin to ensure safe use of the product.

The most common adverse effects associated with vigabatrin tablets include dizziness, fatigue, sleepiness, involuntary eye movement, tremor, blurred vision, memory impairment, weight gain, joint pain, upper respiratory tract infection, aggression, double vision, abnormal coordination, and a confused state.

In 2017, the FDA began a list of off-patent, off-exclusivity branded drugs without approved generics, including Sabril, in an effort to advance the development of generic products.

“Today’s action demonstrates that there is an open pathway to approving products like this one,” FDA Commissioner Scott Gottlieb, MD, said in the release.

According to Dr Gottlieb, the FDA has been focused on new policies aimed at improving the generic review and launch process.

“We know it’s not enough to just approve a record number of generic medicines,” he said. “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.”

The approval of the generic vigabatrin tablets was granted to Teva Pharmaceuticals USA.

References

FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629569.htm. Accessed January 15, 2019.

Sabril Prescribing Information. Sabril’s website. https://www.lundbeck.com/upload/us/files/pdf/Products/Sabril_PI_US_EN.pdf. Accessed January 15, 2019.