Catalyst sues FDA over approval of Firdapse competitor

Citing violations of its own regulations, Catalyst Pharmaceuticals (NASDAQ:CPRX) is suing the FDA over its recent approval (May 6) of Jacobus Pharmaceutical Company’s Ruzurgi (amifampridine) for the treatment of children with an autoimmune disorder called Lambert-Eaton syndrome (LEMS).

The agency approved Catalyst’s Firdapse (amifampridine) for LEMS in November 2018 under Orphan Drug status which is supposed to provide a seven-year period of market exclusivity in the U.S. for the indication.

Shares are down 2% premarket on light volume.

https://seekingalpha.com/news/3470744-catalyst-sues-fda-approval-firdapse-competitor-lems