Valeant Pharmaceuticals International, Inc. and
GlaxoSmithKline announced today that the FDA has approved Potiga™ (ezogabine)
Tablets, a potassium channel opener, as adjunctive treatment of partial-onset
seizures in patients aged 18 years and older.
“We are so pleased to reach such an important milestone
with the U.S.
approval of Potiga by the FDA,” stated Susan Hall, PhD, head of research
and development at Valeant. “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). Final
classification is still under review by the Federal Drug Enforcement
Administration (DEA) and ezogabine will not be available until this process is
Ezogabine is expected to be available in U.S. pharmacies
by the end of the year.