Posted by Michael Wonder on 14 Oct 2023
Catalyst Pharmaceuticals announces FDA acceptance of the supplemental new drug application for Firdapse
13 October 2023 - US FDA assigned target action date of 4 June 2024.
Catalyst Pharmaceuticals today announced that the US FDA has accepted for review the Company's supplemental new drug application to increase the indicated maximum daily dosage of Firdapse (amifampridine) tablets 10 mg from 80 mg to 100 mg for the treatment of Lambert-Eaton myasthenic syndrome.
