FDA — authorised 25 May 2023
- Application: NDA216023
- Marketing authorisation holder: BLUE EARTH
- Local brand name: POSLUMA
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Posluma in United States
FDA authorised Posluma on 25 May 2023
Marketing authorisations
FDA
- Marketing authorisation holder: BLUE EARTH
- Status: approved
Posluma 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 Posluma approved in United States?
Yes. FDA authorised it on 25 May 2023; FDA has authorised it.
Who is the marketing authorisation holder for Posluma in United States?
BLUE EARTH holds the US marketing authorisation.