FDA — authorised 13 April 2022
- Application: BLA761231
- Marketing authorisation holder: AMNEAL PHARMS LLC
- Local brand name: ALYMSYS
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 ALYMSYS in United States
FDA authorised ALYMSYS on 13 April 2022
Marketing authorisation
ALYMSYS 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 ALYMSYS approved in United States?
Yes. FDA authorised it on 13 April 2022.
Who is the marketing authorisation holder for ALYMSYS in United States?
AMNEAL PHARMS LLC holds the US marketing authorisation.