GlaxoSmithKline and Valeant Pharmaceuticals International, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Potiga™ (ezogabine) Tablets, a potassium channel opener, as adjunctive treatment of partial-onset seizures in patients aged 18 years and older. Susan Hall, PhD, head of research and development at Valeant stated, We 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.
FDA has recommended that ezogabine be scheduled as a controlled substance under the Controlled Substances Act (CSA). Finalclassification is still under review by the Federal Drug Enforcement Administration (DEA) and ezogabine will not be available until this process is complete.