FDA — authorised 28 November 2025
- Application: BLA761212
- Marketing authorisation holder: LUPIN LTD
- Local brand name: ARMLUPEG
- Indication: INJECTION — SOLUTION
- Status: approved
🇺🇸 ARMLUPEG in United States
FDA authorised ARMLUPEG on 28 November 2025
Marketing authorisation
ARMLUPEG 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 ARMLUPEG approved in United States?
Yes. FDA authorised it on 28 November 2025.
Who is the marketing authorisation holder for ARMLUPEG in United States?
LUPIN LTD holds the US marketing authorisation.