Orexigen files for Canadian approval of weight loss drug
US drugmaker Orexigen Therapeutics (Nasdaq: OREX) says that medicines regulator 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 company’s weight management product.
The regulatory submission was filed by an affiliate of Canada’s Valeant Pharmaceuticals International (TSX: VRX). 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 commercialization activity and expenses. Valeant expects to begin marketing Contrave in the first half of 2018, if regulatory approval is obtained.
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