FDA — authorised 1 September 2022
- Application: BLA761173
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: STIMUFEND
- Indication: SOLUTION — INJECTION
- Status: approved
FDA authorised STIMUFEND on 1 September 2022
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 1 September 2022; FDA has authorised it.
FRESENIUS KABI USA holds the US marketing authorisation.