FDA — authorised 8 October 2018
- Marketing authorisation holder: ALNYLAM PHARMS INC
- Status: approved
🇺🇸 Onpattro in United States
FDA authorised Onpattro on 8 October 2018
Marketing authorisations
FDA — authorised 6 May 2019
- Application: NDA210922
- Marketing authorisation holder: ALNYLAM PHARMS INC
- Indication: Labeling
- Status: approved
Onpattro in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Onpattro approved in United States?
Yes. FDA authorised it on 8 October 2018; FDA authorised it on 6 May 2019.
Who is the marketing authorisation holder for Onpattro in United States?
ALNYLAM PHARMS INC holds the US marketing authorisation.