SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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|Item 8.01|| |
On June 3, 2021, the Company issued a press release reporting a positive decision in its suit 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
A copy of the Company’s press release is attached as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.
|Item 9.01|| |
Financial Statements and Exhibits.
|99.1||Press release issued by the Company on June 3, 2021.|
|104||Cover Page Interactive Data File (embedded within the inline XBRL document).|
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|Catalyst Pharmaceuticals, Inc.|
Vice President, Treasurer and CFO
Dated: June 3, 2021