FDA rebuts Catalyst charge that price drove Ruzurgi approval decision

While FDA officials discussed the price of Firdapse amifampridine phosphate from Catalyst in internal emails, those documents do not demonstrate that price played a part in the agency’s decision to approve a competing product, the U.S. Department of Justice told a federal court last week.

The U.S. government is defending FDA and HHS against a lawsuit filed by Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX), which markets Firdapse to treat adult patients with Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disease...