The Federal Court of Appeal (FCA) has dismissed Apotex’s appeal arising from its application to end Health Canada’s requirement for additional information establishing the integrity of data from Indian drug manufacturing facilities. The FCA found that the Federal
The Federal Court dismissed an application by Eli Lilly Canada Inc., Ube Industries, Ltd., and Daiichi Sankyo Company, Limited (the Applicants) seeking a prohibition order regarding Apotex’s generic version of Lilly’s EFFIENT® (prasugrel hydrochloride). While the Court rejected
As we reported, Canada implemented sweeping amendments to the Patented Medicines (Notice of Compliance) Regulations on September 21, 2017. Health Canada has now issued an updated guidance document on the administration of the Regulations in light of these amendments.