ALISO VIEJO, Calif., Sept. 21 /PRNewswire-FirstCall/ -- Valeant
Pharmaceuticals International (NYSE: VRX) today provided the following update
on the regulatory applications to the U.S. Food and Drug Administration (FDA)
and the European Medicines Agency (EMEA) for the investigational drug
retigabine, a neuronal potassium channel opener for the adjunctive treatment
for adult epilepsy patients with partial-onset seizures. Scientists from
Valeant and its collaborative partner, GlaxoSmithKline (GSK), met with the FDA
in August to discuss the technical aspects of the planned New Drug Application
(NDA) submission. The file is now being finalized based on the outcome of this
discussion, as well as a final review of data and documents. Valeant and GSK
expect to submit an NDA to the FDA on or before October 23, 2009 and to submit
a Marketing Authorisation Application (MAA) to the EMEA on October 30, 2009.
