Valeant Pharmaceuticals International, an Aliso Viejo-based drug maker, said Tuesday that it may have to wait another three months for a regulatory review of its epilepsy drug candidate.
Valeant and partner GlaxoSmithKline PLC said the Food and Drug Administration extended its target date for reviewing ezogabine to Nov. 30.
Glaxo and Valeant are working together to develop ezogabine, which is aimed at controlling seizures in epileptic patients when other medicines fail.
The companies said that they have already sent in a risk evaluation that the FDA requires.
Earlier this month, a FDA advisory panel gave a regulatory nod to ezogabine, which will have the trade name of Potiga and was previously known as retigabine. The FDA usually follows the recommendation of its panels.
Valeant is in the process of being acquired for $3.2 billion by Biovail Corp., a Canadian drug maker; a shareholder vote is set for late September.
The new company will retain the Valeant name and Chief Executive J. Michael Pearson and is going to move its corporate headquarters from Aliso Viejo to Canada.
