FDA Reviews Valeant Pharmaceuticals’ Retigabine

FDAEuropean Union regulators, as well as the US Food and Drug Administration, are reviewing Valeant Pharmaceuticals’ marketing application for its seizure drug Retigabine. Retigabine is a drug which the company wants to sell for treatment of adult epilepsy patients with partial onset seizures.

The drug, when compared with a placebo, showed that it can effectively reduce seizure rates. Retigabine must be taken three times a day but the competing drugs require less daily dosage.

Valeant Pharmaceuticals have a global licensing and collaboration agreement on Retigabine with GlaxoSmithKline (GSK) in the U. S., Australia, New Zealand, Canada and Puerto Rico, as well as an exclusive license to develop and commercialize the drug elsewhere.

The approval of the drug for marketing across the US could come by next year, and while the FDA has recently accepted the application to review the drug, the EU regulators had sent in their acceptance last month.

Valeant Shares can be seen rising by 19 cents to $32.36.