FDA — authorised 10 April 2020
- Application: NDA213756
- Marketing authorisation holder: ASTRAZENECA
- Indication: Type 1 - New Molecular Entity
- Status: approved
🇺🇸 Koselugo in United States
FDA authorised Koselugo on 10 April 2020
Marketing authorisations
FDA — authorised 10 September 2025
- Application: NDA219943
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: KOSELUGO
- Indication: GRANULE — ORAL
- Status: approved
The US FDA approved Koselugo, developed by AstraZeneca, for its approved indication on 19 November 2025. The application number for this approval is NDA219943. Koselugo was approved through the standard expedited pathway.
Koselugo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Koselugo approved in United States?
Yes. FDA authorised it on 10 April 2020; FDA authorised it on 10 September 2025.
Who is the marketing authorisation holder for Koselugo in United States?
ASTRAZENECA holds the US marketing authorisation.