FDA — authorised 25 April 2024
- Application: BLA761346
- Marketing authorisation holder: ACCORD BIOPHARMA INC.
- Local brand name: HERCESSI
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 HERCESSI in United States
FDA authorised HERCESSI on 25 April 2024
Marketing authorisations
FDA
- Status: approved
HERCESSI in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is HERCESSI approved in United States?
Yes. FDA authorised it on 25 April 2024; FDA has authorised it.
Who is the marketing authorisation holder for HERCESSI in United States?
ACCORD BIOPHARMA INC. holds the US marketing authorisation.