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January 6, 2014
08:15 EDTCPRXCatalyst reports successful completion of Type B therapy meeting with FDA
Catalyst Pharmaceutical announced the successful completion of a Type B meeting with the FDA about Firdapse tablets, its lead product being evaluated for the treatment of Lambert Eaton Myasthenic Syndrome, or LEMS. Catalyst provided FDA with an update on the development program for Firdapse, which received Breakthrough Therapy designation from the FDA in August 2013. The company also confirmed with FDA the clinical, nonclinical, and chemistry and manufacturing controls requirements that FDA will require to approve a New Drug Application for Firdapse. This Type B meeting with the FDA was Catalyst's first meeting as the sponsor of the IND for Firdapse. Catalyst will file rolling submissions of the NDA modules as completed in anticipation of receiving a priority review of its NDA for Firdapse. The Company provided a briefing package to the FDA that described all completed, in-progress, and planned preclinical studies, clinical studies, and drug manufacturing activities. This package included summaries of 54 preclinical studies, six clinical studies, and information related to drug manufacturing. The FDA concurred that the Company's completed, in-progress, and planned development activities represented a nearly complete package of information that would be needed for a complete NDA.
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July 22, 2015
13:26 EDTCPRXCatalyst Pharmaceutical initiates rolling NDA submission for Firdapse
Catalyst Pharmaceuticals announced the initiation of a rolling submission of a New Drug Application to the U.S. FDA for Firdapse for the treatment of Lambert-Eaton Myasthenic Syndrome. Firdapse has received Breakthrough Therapy Designation from the FDA for the treatment of LEMS, as well as orphan drug designations for LEMS and congenital myasthenic syndromes. The company said, “We expect to complete the submission of the NDA in the fourth quarter of 2015, at which time we will be requesting a Priority Review of our application. We will continue to work closely with the FDA as we seek approval of the NDA."

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