🇺🇸 Xolremdi in United States

FDA authorised Xolremdi on 26 April 2024

Marketing authorisations

FDA — authorised 26 April 2024

Application: NDA218709
Marketing authorisation holder: X4 PHARMS
Local brand name: XOLREMDI
Indication: CAPSULE — ORAL
Status: approved

The FDA approved Xolremdi, a new molecular entity, on 26 April 2024. The marketing authorisation holder is X4 PHARMS. The application was submitted under the standard expedited pathway. The indication approved for Xolremdi is Type 1, which refers to a new molecular entity.

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FDA

Marketing authorisation holder: X4 PHARMS
Status: approved

Xolremdi in other countries

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

Other Infectious Disease approved in United States

Frequently asked questions

Is Xolremdi approved in United States?

Yes. FDA authorised it on 26 April 2024; FDA has authorised it.

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

X4 PHARMS holds the US marketing authorisation.