Catalyst Pharmaceuticals Files Federal Lawsuit Against U.S. Food and Drug Administration
The complaint alleges that the defendants’ approval of Ruzurgi violated multiple provisions of
“New chemical entities (drugs) are required to go through the full drug approval process which requires demonstration of safety and efficacy,” said
Firdapse is currently being evaluated in clinical trials for the treatment of MuSK-MG, CMS, and SMA Type 3 and has received Orphan Drug Designation from the
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 Catalyst's suit to vacate the
Brian KorbSolebury Trout (646) 378-2923 firstname.lastname@example.org Company Contact Patrick J. McEnany Catalyst PharmaceuticalsChief Executive Officer (305) 420-3200 email@example.com Media Contact David Schull Russo Partners(212) 845-4271 firstname.lastname@example.org
Source: Catalyst Pharmaceuticals, Inc.