Catalyst Pharma Reports FDA Acceptance Of SNDA For FIRDAPSE

(RTTNews) - Catalyst Pharmaceuticals, Inc. (CPRX) reported on Friday that the FDA has approved its supplementary New Drug Application (sNDA) to raise the indicated maximum daily dosage of FIRDAPSE (amifampridine) Tablets 10 mg for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) from 80mg to 100mg.

Patrick J. McEnany, Chairman and CEO of Catalyst said, "We are pleased by the Agency's acceptance of the sNDA filing for FIRDAPSE … It has proven to be an important therapeutic option for individuals in the U.S. affected by LEMS, including those comorbid with small-cell lung cancer. If approved, this will offer additional indicated dosage options for LEMS patients who may benefit from a FIRDAPSE daily dosage greater than 80mg."

The FDA has set a Prescription Drug User Fee Act action date of June 4, 2024, for the sNDA.