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Catalyst Pharmaceuticals, Inc.’s and KYE Pharmaceuticals’ Lawsuit in Canadian Federal Court Quashes the Notice of Compliance (NOC) for Ruzurgi®
- Without an NOC, Ruzurgi® is without a Marketing Authorization in Canada - Matter Remanded Back to Health Canada to Provide a More Transparent Record of Its
About this update from Catalyst Pharmaceuticals, Inc.
[{"type":"text","content":"- Without an NOC, Ruzurgi® is without a Marketing Authorization in Canada - Matter Remanded Back to Health Canada to Provide a More Transparent Record of Its Decision in Light of Firdapse®’s Data Protection CORAL GABLES, Fla., June 03, 2021 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (\"Catalyst\") (Nasdaq: CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing and commercializing novel high-quality medicines for patients living with rare diseases, and KYE Pharmaceuticals Inc. (\"KYE\"), a private company headquartered in Mississauga, Ontario and focused on bringing medicines that fulfill clinically significant unmet needs to the Canadian market, today announced a positive decision in their lawsuit in Canadian Federal Court challenging Health Canada’s approval of Medunik’s New Drug Submission (NDS) for Ruzurgi®. The lawsuit sought judicial review of Health Canada’s decision to approve the NDS for Ruzurgi® (Jacobus Pharmaceutical’s amifampridine product distributed in Canada by Medunik) and issue a Notice of Compliance (\"NOC\") on August 10, 2020, as unreasonable due to Ruzurgi®’s product monograph and NDS explicitly referencing data included in Firdapse®’s NDS, approved by Health Canada on July 31, 2020 and given data protection as an Innovative Drug as of that date. The Judge’s decision quashes the NOC previously issued for Ruzurgi® and remands the matter to the Minister of Health to redetermine its decision to grant marketing authorization to Ruzurgi® in spite of Firdapse®’s data protection rights. This leaves Ruzurgi® without marketing authorization in Canada. “We are very pleased that the Judge has taken seriously the need to protect Firdapse®’s data exclusivity,” said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst. “New chemical entities like Firdapse®, are required to go through a thorough drug approval process in Canada, requiring an exacting demonstration of safety and efficacy, and, in exchange for that effort, Health Canada regulations are supposed to prevent other pharmaceutical companies from being able to use the innovative drug’s data in their NDS for 8 years from the date of the Notice of Compliance. In Firdapse®’s case, Health Canada allowed Medunik to use Catalyst's protected data in its application for Ruzurgi® during the data exclu...