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
- Matter Remanded Back to
The lawsuit sought judicial review of Health Canada’s decision to approve the NDS for Ruzurgi® (Jacobus Pharmaceutical’s amifampridine product distributed in
“We are very pleased that the Judge has taken seriously the need to protect Firdapse®’s data exclusivity,” said
“As the company marketing Firdapse® in Canada,” added
Firdapse® is currently being evaluated in clinical trials for the treatment of MuSK-MG and has received Orphan Drug Designation from the FDA for myasthenia gravis.
Catalyst's Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether KYE can successfully commercialize Firdapse® in
David Schull Russo Partners(212) 845-4271 email@example.com Company Contact Patrick J. McEnany Catalyst PharmaceuticalsChief Executive Officer (305) 420-3200 firstname.lastname@example.org
Source: Catalyst Pharmaceuticals, Inc.