The FDA has granted two New Drug Application (NDA) approvals for vigabatrin tablets and oral solution (Sabril, H. Lundbec) to treat infantile spasms in children from one month to two years of age. Sabril is the first drug in the U.S. indicated for this severe type of seizure, which usually appears in the first year of life.
The tablets have been approved for adults in combination with other medications to treat complex partial seizures that have not responded adequately to previous drug therapies.
Damage to vision is an important safety concern. A boxed warning will be included to alert health care professionals to the risk of a progressive loss of peripheral vision with a potential decrease in visual acuity. Even the lowest doses can cause vision damage. The drug will be available only through a restricted distribution program.
Sabril drug was designated as an orphan drug for use in treating infantile spasms.
Source FDA, August 21, 2009