Posted by Michael Wonder on 26 Apr 2017
Orexigen Therapeutics announces new drug submission for Contrave in Canada
25 April 2017 - Orexigen Therapeutics today announced that Health Canada has completed its screening phase and accepted for review a new drug submission for marketing approval of Contrave (naltrexone hydrochloride and bupropion hydrochloride).
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 distributorship agreement with Orexigen, executed in August 2016.
Under the terms of the agreement, Valeant is responsible for obtaining regulatory approval and for all commercialisation activity and expenses. Valeant expects to begin marketing Contrave in the first half of 2018, if regulatory approval is obtained.
