Sunovion submits supplemental new drug application to FDA for use of Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in children 4 years of age and older

Sunovion Pharmaceuticals

15 March 2017 - If approved, Aptiom would provide an important new monotherapy or adjunctive therapy treatment option for individuals as early as four years of age who experience partial-onset seizures.

Sunovion Pharmaceuticals today announced that it has submitted a supplemental new drug application (sNDA) to the U.S. FDA to expand the indication for its anti-epileptic drug Aptiom (eslicarbazepine acetate) to include use as monotherapy or adjunctive therapy for the treatment of partial-onset seizures in children four years of age and older.

Read Sunovion Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , US , Submission , Paediatrics