🇺🇸 Nucala in United States

FDA authorised Nucala on 4 November 2015 · 39,889 US adverse-event reports

Marketing authorisations

FDA — authorised 4 November 2015

  • Application: BLA125526
  • Marketing authorisation holder: GLAXOSMITHKLINE LLC
  • Status: supplemented

FDA — authorised 6 June 2019

  • Application: BLA761122
  • Marketing authorisation holder: GLAXOSMITHKLINE
  • Status: supplemented

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Asthma — 7,301 reports (18.3%)
  2. Dyspnoea — 6,186 reports (15.51%)
  3. Product Dose Omission Issue — 5,187 reports (13%)
  4. Wheezing — 4,571 reports (11.46%)
  5. Therapeutic Product Effect Incomplete — 3,543 reports (8.88%)
  6. Drug Ineffective — 2,994 reports (7.51%)
  7. Cough — 2,744 reports (6.88%)
  8. Loss Of Personal Independence In Daily Activities — 2,704 reports (6.78%)
  9. Off Label Use — 2,620 reports (6.57%)
  10. Sleep Disorder Due To A General Medical Condition — 2,039 reports (5.11%)

Source database →

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 6 June 2019; FDA has authorised it.

Who is the marketing authorisation holder for Nucala in United States?

GLAXOSMITHKLINE LLC holds the US marketing authorisation.