Lupin’s Firdapse generic wins FDA approval, pending patent resolution
The U.S. Food and Drug Administration (FDA) has tentatively approved Lupin’s generic version of Firdapse (amifampridine) for people with Lambert-Eaton myasthenic syndrome (LEMS), ages 6 and older, according to a company press release. This means the treatment satisfies all the requirements to be marketed in the U.S.