Generic version of seizure drug Sabril gets FDA approval

The FDA has announced approval of the first generic version of Sabril (vigabatrin) 500mg tablets to help treat seizures in adults and pediatric patients with epilepsy.

Vigabatrin tablets are FDA-approved for the treatment of refractory complex partial seizures, also called focal seizures, as an adjunctive therapy in patients 10 years of age and older who have responded inadequately to several alternative treatments.

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

"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," commented FDA Commissioner Scott Gottlieb after approval of Teva Pharmaceuticals USA’s Sabril.

"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," he said.

The FDA requires appropriate data and information to demonstrate that generic drugs meet the agency’s rigorous approval standards to ensure quality drug products that are as safe and effective as their brand name counterparts. As with brand-name drugs, the FDA also inspects manufacturing and packaging facilities for generic drugs to ensure that they are capable of consistently producing quality products.

"We know there has been past interest in developing a generic alternative to this product. Earlier this year, we also highlighted this drug, along with many others, on a list of off-patent, off-exclusivity branded drugs without approved generics, to clarify that there were no patents or exclusivities that should impede its approval.

"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."

Labeling for vigabatrin tablets includes a boxed warning for permanent vision loss. The most common side effects associated with vigabatrin tablets include dizziness, fatigue, sleepiness (somnolence), involuntary eye movement (nystagmus), tremor, blurred vision, memory impairment, weight gain, joint pain (arthralgia), upper respiratory tract infection, aggression, double vision (diplopia), abnormal coordination and a confused state. Serious side effects associated with vigabatrin tablets include permanent vision loss and risk of suicidal thoughts or actions.

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