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news.Valeant to collaborate with GSK on the development and marketing of Retigabine
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The FDA has accepted to review the New Drug Application (NDA) seeking marketing approval for the investigational drug, Retigabine developed by Valeant Pharmaceuticals International (Valeant). Retigabine is a neuronal potassium channel opener for the adjunctive treatment for adult epilepsy patients with partial-onset seizures.
In addition, the European Medicines Agency (EMEA) confirmed on November 17, 2009 that the MAA was successfully validated, thus enabling the MAA review to commence. The filings were submitted on October 30, 2009.
Valeant has a worldwide license and collaboration agreement with GlaxoSmithKline (GSK), to develop and commercialise Retigabine. Valeant is expected to collaborate with GSK on the development and marketing of Retigabine in the US, Australia, New Zealand, Canada and Puerto Rico (Collaboration Territory).
Additionally, GSK has an exclusive license to develop and commercialise retigabine in countries outside of the Collaboration Territory and certain backup compounds to retigabine worldwide.