FDA — authorised 9 March 2011
- Application: BLA125370
- Marketing authorisation holder: HUMAN GENOME SCIENCES INC.
- Status: supplemented
🇺🇸 Benlysta in United States
FDA authorised Benlysta on 9 March 2011
Marketing authorisations
FDA — authorised 20 July 2017
- Application: BLA761043
- Marketing authorisation holder: GLAXOSMITHKLINE LLC
- Status: supplemented
FDA
- Status: approved
Benlysta in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Benlysta approved in United States?
Yes. FDA authorised it on 9 March 2011; FDA authorised it on 20 July 2017; FDA has authorised it.
Who is the marketing authorisation holder for Benlysta in United States?
HUMAN GENOME SCIENCES INC. holds the US marketing authorisation.