Three controlled clinical trails comprising 1,239 adult patients have established the efficacy of ezogabine as adjunctive therapy in partial onset seizures.
The companies plan to introduce the product by the end of the year in the US.
The FDA has recommended that ezogabine be scheduled as a controlled substance under the Controlled Substances Act (CSA).
Valeant Research and Development head Susan Hall said they are so pleased to reach such an important milestone with the US approval of Potiga by the FDA.
"We believe this product will play a needed role in the management of partial onset seizures in appropriate patients who are uncontrolled on their current medications," Hall said.