The FDA announced the approval of Sabril (vigabatrin; Lundbeck) as add-on therapy for the treatment of refractory complex partial seizures (CPS) in children 10 years of age and older with inadequate response to other treatments and if the possible benefit outweighs the risk of vision loss.

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This approval expands the age range of Sabril’s previous indication as adjunctive therapy for adults with refractory CPS who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Sabril is not indicated as a first-line agent for refractory CPS.

In addition to its refractory CPS indication, Sabril is approved as monotherapy for infantile spasms in babies one month to two years of age if the possible benefit outweighs the potential risk of vision loss.

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Sabril is already available in 500mg strength tablets and 500mg strength packets as powder for oral solution.

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