Valeant-GlaxoSmithKline Gets FDA Approval for Potiga
Monday, June 13, 2021 5:55 AM

Valeant Pharmaceuticals International Inc. (NYSE: VRX) and GlaxoSmithKline Plc (NYSE: GSK) said today 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.

"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."

The FDA has recommended that Potiga, known generically as ezogabine, be scheduled as a controlled substance, with final classification still under review. It's expected to be available in U.S. pharmacies by the end of the year. The FDA said a Risk Evaluation and Mitigation Strategy will be needed for ezogabine to inform health-care professionals of the risk of urinary retention, seen in clinical trials, and symptoms of acute urinary retention.

Shares of Valeant closed lower by 1.80 percent to $52.83 and GlaxoSmithKline’s shares lost 1.61 percent to close at $41.57 on Friday.