Catalyst Pharmaceuticals announced that its collaboration partner, DyDo Pharma reported that it has submitted a New Drug Application to Japan’s Pharmaceuticals and Medical Devices Agency seeking marketing approval for FIRDAPSE Tablets 10 mg, for the treatment of Lambert Eaton myasthenic syndrome in Japan. The submission is based on preliminary favorable analysis results of interim data after six months into the safety phase of the registration study to evaluate the efficacy and safety of FIRDAPSE for the treatment of LEMS. The review period is expected to be approximately a minimum of nine months from the submission date.
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