FDA — authorised 30 June 2021
- Application: BLA761179
- Marketing authorisation holder: JAZZ PHARMS
- Indication: Type 1 - New Molecular Entity
- Status: approved
🇺🇸 Elspar in United States
FDA authorised Elspar on 30 June 2021
Marketing authorisation
Elspar 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 Elspar approved in United States?
Yes. FDA authorised it on 30 June 2021.
Who is the marketing authorisation holder for Elspar in United States?
JAZZ PHARMS holds the US marketing authorisation.