Posted by Michael Wonder on 12 Mar 2022
Catalyst Pharmaceuticals and KYE Pharmaceuticals announce a second favourable Canadian Federal Court ruling setting aside approval of Ruzurgi
11 March 2022 - Catalyst Pharmaceuticals and KYE Pharmaceuticals today announced receipt of a favourable decision from the Federal Court of Canada setting aside for the second time the decision of Canada’s national healthcare regulatory agency, Health Canada, to approve Ruzurgi (amifampridine) for Lambert-Eaton myasthenic syndrome patients.
This decision sets aside the Notice of Compliance issued by Health Canada for Ruzurgi due to the inclusion of data developed for Firdapse, which is protected from such use due to Firdapse’s status as an innovative drug in Canada.
