🇺🇸 Qfitlia in United States

FDA authorised Qfitlia on 28 March 2025

Marketing authorisations

FDA — authorised 28 March 2025

Application: NDA219019
Marketing authorisation holder: GENZYME CORP
Local brand name: QFITLIA
Indication: SOLUTION — SUBCUTANEOUS
Status: approved

The FDA approved Qfitlia, a new molecular entity, on 28 March 2025. The marketing authorisation was granted to Genzyme Corp under standard expedited pathway. The approval was based on the NDA219019 application.

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FDA

Marketing authorisation holder: GENZYME CORP
Status: approved

Qfitlia in other countries

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

Other Rare Disease approved in United States

Frequently asked questions

Is Qfitlia approved in United States?

Yes. FDA authorised it on 28 March 2025; FDA has authorised it.

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

GENZYME CORP holds the US marketing authorisation.