FDA — authorised 5 September 2019
- Application: BLA761102
- Marketing authorisation holder: SERVIER PHARMA LLC
- Indication: Labeling
- Status: approved
FDA authorised Asparlas on 5 September 2019
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 5 September 2019.
SERVIER PHARMA LLC holds the US marketing authorisation.