CPRX - Catalyst to appeal ruling in favor of FDA decision on Firdapse's competitor drug

Catalyst Pharmaceuticals slides ([[CPRX]] -7.8%) after a federal judge upheld a previous rule from a Magistrate Judge, granted summary judgment in favor of the FDA and Jacobus and dismissed the company’s lawsuit against the FDA regarding the approval of a rival drug, Ruzurgi for the treatment of Lambert-Eaton Myasthenic Syndrome ((LEMS)) from Jacobus Pharmaceutical.According to Catalyst’s statement, the judge said the strict interpretation of the Orphan Drug Act used by Catalyst is not necessarily wrong, but was “not the only reasonable way to interpret.” The judge said the language was ambiguous and, as a result, adopted the FDA’s interpretation.The judge also rejected Catalyst’s argument that the approved labeling for Jacobus’s Ruzurgi is false and misleadingThe company says it plans to appeal decision by district judge to the 11th Circuit Court of Appeals.Last month, Catalyst filed a proceeding in a Canadian federal court challenging Health Canada's approval of Ruzurgi.

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Catalyst to appeal ruling in favor of FDA decision on Firdapse's competitor drug