Posted by Michael Wonder on 27 Aug 2020
KYE Pharmaceuticals and Catalyst Pharmaceuticals challenge Health Canada’s decision to overlook Firdapse data exclusivity
26 August 2020 - Catalyst Pharmaceuticals and KYE Pharmaceuticals today announced the filing of a proceeding in Canadian Federal Court challenging Health Canada’s issuance of a Notice of Compliance on 10 August 2020 for Medunik’s new drug submission for the drug Ruzurgi (amifampridine) for the treatment of Lambert-Eaton Myasthenic Syndrome despite the fact that Catalyst’s Firdapse (amifampridine phosphate) was issued an Notice of Compliance on 31 July 2020 and was granted data protection as an “innovative drug” as it was the first amifampridine product to be approved in Canada.
