FDA — authorised 20 November 2015
- Marketing authorisation holder: MILLENNIUM PHARMS
- Status: approved
🇺🇸 Ninlaro in United States
FDA authorised Ninlaro on 20 November 2015
Marketing authorisations
FDA — authorised 28 April 2022
- Application: NDA208462
- Marketing authorisation holder: TAKEDA PHARMS USA
- Indication: Labeling
- Status: approved
Ninlaro 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 Ninlaro approved in United States?
Yes. FDA authorised it on 20 November 2015; FDA authorised it on 28 April 2022.
Who is the marketing authorisation holder for Ninlaro in United States?
MILLENNIUM PHARMS holds the US marketing authorisation.