ARTICLE | Politics, Policy & Law
Court backs exclusivity for $375K Catalyst drug
A federal appeals court ruled FDA’s attempt to thwart high price for old drug violates Orphan Drug Act
October 1, 2021 1:20 AM UTC
In a ruling that imposes limits on FDA’s ability to stretch the Orphan Drug Act to reduce drug prices, an appeals court ruled Thursday that the agency’s approval of Ruzurgi from Jacobus violated the act.
The U.S. Court of Appeals for the Eleventh Circuit sets the stage for Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX) to exercise market exclusivity in the U.S. until November 2025 for Firdapse amifampridine to treat Lambert-Eaton myasthenic syndrome (LEMS)...