Competitive consequences

Whatever the reason FDA refused to file an NDA for Catalyst Pharmaceuticals Inc.'s Firdapse amifampridine, the delay could allow a competitor with a less expensive form of the molecule to gain ground in a race to market.

Since Firdapse and 3,4-diaminopyridine (3,4-DAP) from Jacobus Pharmaceutical Co. Inc. have the same active ingredient, and both have Orphan Drug designation to treat Lambert-Eaton myasthenic syndrome (LEMS), only the first one approved will be allowed on the market for seven years...