Catalyst Pharmaceuticals is a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, first- or best-in-class medicines for other rare diseases. Catalyst's New Drug Application for FIRDAPSE® (amifampridine) Tablets 10 mg for the treatment of adults with Lambert-Eaton myasthenic syndrome ("LEMS") was approved in 2018 by the U.S. Food & Drug Administration ("FDA"), and FIRDAPSE is commercially available in the United States as a treatment for adults with LEMS. Further, Canada's national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS.

Pharmaceutical

Catalyst Pharmaceuticals

Patrick J. McEnany 

Gary Ingenito

Jeff Del Carmen

Preethi Sundaram

Steven R. Miller

Alicia Grande

Brian Elsbernd

The Regulatory and Compliance team at Catalyst Pharmaceuticals is responsible for ensuring that the company adheres to all regulatory requirements and compliance standards set by healthcare authorities. This team manages the submission of regulatory filings, oversees quality systems, and ensures that all products meet safety and efficacy standards. They play a crucial role in maintaining the integrity of the company’s operations and facilitating the successful approval and commercialization of novel medicines for rare diseases.

Regulatory and Compliance

Medical Affairs and Patient Advocacy

Board and Governance

Leadership Team

Regulatory and Compliance

About

Team members

Other teams at Catalyst Pharmaceuticals

Medical Affairs and Patient Advocacy

Board and Governance

Leadership Team