🇺🇸 Firdapse in United States

FDA authorised Firdapse on 28 November 2018

Marketing authorisations

FDA — authorised 28 November 2018

Application: NDA208078
Marketing authorisation holder: CATALYST PHARMS
Local brand name: FIRDAPSE
Indication: TABLET — ORAL
Status: approved

The FDA approved Firdapse, manufactured by Catalyst Pharmaceuticals, for the treatment of Lambert-Eaton myasthenic syndrome (LEMS). LEMS is a rare autoimmune disorder that affects the nerve-muscle connection, causing muscle weakness and fatigue. This approval was granted based on the drug's efficacy.

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FDA

Application: NDA209321
Marketing authorisation holder: JACOBUS PHARM CO INC
Local brand name: RUZURGI
Indication: TABLET — ORAL
Status: approved

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Firdapse in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Neuroscience approved in United States

Frequently asked questions

Is Firdapse approved in United States?

Yes. FDA authorised it on 28 November 2018; FDA has authorised it.

Who is the marketing authorisation holder for Firdapse in United States?

CATALYST PHARMS holds the US marketing authorisation.