The Food and Drug Administration (FDA) has approved an abbreviated New Drug Application for Vigadrone (vigabatrin for oral solution; Aucta), the generic alternative to Sabril (vigabatrin; Lundbeck) powder for oral solution.
Vigadrone is indicated for adjunctive therapy in patients ≥10 years of age with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss; it is not a-first line agent for CPS.
The product is also approved as monotherapy for infantile spasms in patients 1 month to 2 years of age, when the potential benefits outweigh the risk of vision loss.
Like Sabril, Vigadrone carries a Boxed Warning regarding the risk of permanent vision loss and is only available to healthcare professionals and patients under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program.
Vigadrone is supplied as 500mg packets containing a granular powder for reconstitution. Each carton contains 50 packets.
For more information call (866) 244-8175 or visit www.Vigadrone.com.