Orexigen Therapeutics a biopharmaceutical company, said Health Canada has completed its screening phase and accepted for review a new drug submission for marketing approval of Contrave (naltrexone HCl and bupropion HCl). The regulatory submission was filed by Valeant Canada, an affiliate of Valeant Pharmaceuticals International Inc. If approved, Valeant will market and distribute Contrave in Canada as part of its 2016 distributorship agreement with Orexigen.
Under the terms of the deal, Valeant is responsible for obtaining regulatory approval and for all commercialization activity and expenses. Valeant said expects to begin marketing Contrave in the first half of 2018, if regulatory approval is obtained.