Bausch Health Companies Inc (BHC)

[mlkrborn]

Valeant Pharmaceuticals and GlaxoSmithKline (GSK) receive FDA approval of Potiga (VRX) 52.83 : Co and GSK announce the FDA has approved Potiga Tablets, a potassium channel opener, as adjunctive treatment of partial-onset seizures in patients aged 18 years and older. Ezogabine is expected to be available in U.S. pharmacies by the end of the year. FDA has determined that a Risk Evaluation and Mitigation Strategy will be necessary for ezogabine, with the goal of informing healthcare professionals of the risk of urinary retention and the symptoms of acute urinary retention. Ezogabine caused urinary retention in clinical trials. Urinary retention was reported as an adverse event in 29 out of 1,365 (~2%) patients treated with ezogabine. In all studies of patients with partial-onset seizures, including open-label studies, five patients required catheterization.