FDA — authorised 23 November 2020
- Marketing authorisation holder: ALNYLAM PHARMS INC
- Status: approved
🇺🇸 Oxlumo in United States
FDA authorised Oxlumo on 23 November 2020
Marketing authorisations
FDA — authorised 23 November 2020
- Application: NDA214103
- Marketing authorisation holder: ALNYLAM PHARMS INC
- Local brand name: OXLUMO
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
Oxlumo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Oxlumo approved in United States?
Yes. FDA authorised it on 23 November 2020; FDA authorised it on 23 November 2020.
Who is the marketing authorisation holder for Oxlumo in United States?
ALNYLAM PHARMS INC holds the US marketing authorisation.