The FDA has approved Sabril (vigabatrin) oral solution to treat infantile spasms in children aged 1 month to 2 years.
Sabril (vigabatrin) Tablets have been approved for adult use, in combination with other medications, to treat complex partial seizures that have not responded adequately to previous drug therapies. Sabril was designated as an orphan drug by the FDA for use in treating infantile spasms.
Russell Katz, director of the division of neurology products at the FDA’s Center for Drug Evaluation and Research, said: “Seizures can cause impaired nervous system function and reduced quality of life. Infantile spasms in children this young are very serious and this approval provides these patients and their parents a treatment option.”