This is the first generic approval of the tablet form of vigabatrin, which is indicated for treating focal seizures in patients with epilepsy.
The US Food and Drug Administration (FDA) has approved the first generic version of vigabatrin 5oo mg tablets, an adjunctive therapy for treating complex partial seizures, or focal seizures, in adult and pediatric patients.
Vigabatrin, which is also sold under the brand name Sabril, is indicated for patients 10 years of age and older who have not responded adequately to multiple alternative treatments for epilepsy.
The FDA has emphasized support for generics and encouraged pharmaceutical companies to pursue generics by highlighting branded drugs without restrictions for generic versions.
"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. Today's action demonstrates that there is an open pathway to approving products like this one,” said FDA Commissioner Scott Gottlieb, MD, in a statement.
Vigabatrin was originally approved in 2009 and is available in 2 forms: tablets and powder for oral solution. Generic versions of vigabatrin power have previously been approved.
The most common adverse side effects for vigabatrin tablets include dizziness, fatigue, somnolence, nystagmus, tremor, blurred vision, memory impairment, weight gain, arthralgia, upper respiratory tract infection, aggression, diplopia, abnormal coordination, and a confused state.
The Vigabatrin Prescribing Information contains a boxed warning about the potential for a decrease in visual acuity as well as permanent vision loss. Additionally, the label includes warnings about the potential for suicidal behavior and ideation, anemia, and abnormal MRI changes.
“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,” added Gottlieb. “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."