Catalyst Says FDA Is Breaking Law By Approving Rival's Drug

Law360 (September 22, 2020, 5:02 PM EDT) -- Catalyst Pharmaceuticals Inc. fought Tuesday against a federal judge's determination that the U.S. Food and Drug Administration lawfully approved a lower-cost version of a drug that treats a rare autoimmune disease, arguing that the Orphan Drug Act does not allow the approval of two drugs to treat the same disease.

In a Zoom hearing before U.S. District Judge Beth Bloom, Catalyst's attorney Philip Perry told the court that U.S. Magistrate Judge Lauren Louis got it wrong when she recommended denying summary judgment to the Florida-based pharmaceutical company, which is suing the FDA over its approval of Jacobus Pharmaceutical Co. Inc.'s Ruzurgi,...

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