FDA — authorised 4 November 2015
- Marketing authorisation holder: GLAXOSMITHKLINE LLC
- Status: approved
🇺🇸 Nucala in United States
FDA authorised Nucala on 4 November 2015
Marketing authorisations
FDA — authorised 4 November 2015
- Application: BLA125526
- Marketing authorisation holder: GLAXOSMITHKLINE LLC
- Local brand name: NUCALA
- Indication: INJECTABLE — SUBCUTANEOUS LYOPHILIZED POWER
- Status: approved
FDA — authorised 6 June 2019
- Application: BLA761122
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: NUCALA
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
The FDA approved Nucala, a product of GlaxoSmithKline, for its approved indication on August 6, 2025. The application number for this approval is BLA761122. Nucala was approved through the standard expedited pathway.
Nucala in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in United States
Frequently asked questions
Is Nucala approved in United States?
Yes. FDA authorised it on 4 November 2015; FDA authorised it on 4 November 2015; FDA authorised it on 6 June 2019.
Who is the marketing authorisation holder for Nucala in United States?
GLAXOSMITHKLINE LLC holds the US marketing authorisation.