FDA — authorised 4 November 2015
- Application: BLA125526
- Marketing authorisation holder: GLAXOSMITHKLINE LLC
- Local brand name: NUCALA
- Indication: INJECTABLE — SUBCUTANEOUS LYOPHILIZED POWER
- Status: approved
🇺🇸 Mepolizumab 300 mg in United States
FDA authorised Mepolizumab 300 mg on 4 November 2015
Marketing authorisations
FDA — authorised 6 June 2019
- Application: BLA761122
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: NUCALA
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA
- Status: approved
Mepolizumab 300 mg in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Mepolizumab 300 mg approved in United States?
Yes. FDA authorised it on 4 November 2015; FDA authorised it on 6 June 2019; FDA has authorised it.
Who is the marketing authorisation holder for Mepolizumab 300 mg in United States?
GLAXOSMITHKLINE LLC holds the US marketing authorisation.