The FDA has approved Sabril (vigabatrin, from Lundbeck) oral solution as monotherapy for infantile spasms in children 1 month to 2 years of age. Sabril tablets have been approved for use in adults as adjunctive therapy in the treatment of refractory complex partial seizures that have responded inadequately to several alternative treatments. Sabril is associated with a risk of progressive loss of peripheral vision with potential decrease in visual acuity, and thus is only indicated when the benefits of treatment outweigh the potential risk of vision loss. Because of the risk of permanent vision damage, Sabril will be available only through the restricted distribution program SHARE (Support Help and Resources for Epilepsy).

Sabril is expected to be available in the third quarter of 2009 as 500mg packets of powder for oral solution and as 500mg dosage strength tablets.

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