Vigadrone Available for Refractory Complex Partial Seizures, Infantile Spasms

The FDA has approved an abbreviated New Drug Application for Vigadrone, the generic alternative to Sabril powder for oral solution.

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.

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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 VigabatrinREMS.com.

This article originally appeared on MPR