UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Item 8.01 | Other Events |
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. |
(d) 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). |
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SIGNATURES
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. | ||
By: | /s/ Alicia Grande | |
Alicia Grande | ||
Vice President, Treasurer and CFO |
Dated: June 3, 2021
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