FDA — authorised 2 October 2018
- Marketing authorisation holder: PARATEK PHARMS INC
- Status: approved
🇺🇸 Nuzyra in United States
FDA authorised Nuzyra on 2 October 2018
Marketing authorisations
FDA — authorised 2 September 2020
- Application: NDA209817
- Marketing authorisation holder: PARATEK PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 20 October 2020
- Application: NDA209816
- Marketing authorisation holder: PARATEK PHARMS
- Indication: Labeling
- Status: approved
Nuzyra 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 Nuzyra approved in United States?
Yes. FDA authorised it on 2 October 2018; FDA authorised it on 2 September 2020; FDA authorised it on 20 October 2020.
Who is the marketing authorisation holder for Nuzyra in United States?
PARATEK PHARMS INC holds the US marketing authorisation.