🇺🇸 Agamree in United States

FDA authorised Agamree on 26 October 2023

Marketing authorisations

FDA — authorised 26 October 2023

Application: NDA215239
Marketing authorisation holder: CATALYST PHARMS
Local brand name: AGAMREE
Indication: SUSPENSION — ORAL
Status: approved

The FDA approved Agamree, developed by Catalyst Pharms, on June 5, 2024. The approval was granted through a standard expedited pathway. The approved indication for Agamree is listed in its labeling, but the specific indication and local brand name are not reported in the available data.

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FDA

Marketing authorisation holder: CATALYST PHARMS
Status: approved

Agamree in other countries

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

Other Immunology approved in United States

Frequently asked questions

Is Agamree approved in United States?

Yes. FDA authorised it on 26 October 2023; FDA has authorised it.

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

CATALYST PHARMS holds the US marketing authorisation.