GSK, Valeant receive FDA approval for Potiga

RESEARCH TRIANGLE PARK, N.C. — The Food and Drug Administration has approved a new drug for epilepsy made by GlaxoSmithKline and Valeant Pharmaceuticals International, the drug makers said Monday.

The FDA approved Potiga (ezogabine) tablets for the treatment of partial-onset seizures in patients ages 18 years and older.

“We are so pleased to reach such an important milestone with the U.S. approval of Potiga by the FDA,” Valeant head of research and development Susan Hall said. “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.”

The FDA has recommended that the drug be scheduled as a controlled substance, and it won’t be available until the Drug Enforcement Administration makes a final decision on how to classify it, but the drug makers said they expected that to happen by the end of the year.