🇺🇸 ASPARAGINASE ERWINIA CHRYSANTHEMI in United States

FDA authorised ASPARAGINASE ERWINIA CHRYSANTHEMI on 30 June 2021 · 160 US adverse-event reports

Marketing authorisation

FDA — authorised 30 June 2021

  • Application: BLA761179
  • Marketing authorisation holder: JAZZ PHARMS
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

Read official source →

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. Febrile Neutropenia — 52 reports (32.5%)
  2. Hypersensitivity — 17 reports (10.62%)
  3. Aspergillus Infection — 13 reports (8.12%)
  4. Off Label Use — 13 reports (8.12%)
  5. Tracheitis — 13 reports (8.12%)
  6. Drug Ineffective — 12 reports (7.5%)
  7. Vomiting — 12 reports (7.5%)
  8. Rhinovirus Infection — 11 reports (6.88%)
  9. Thrombocytopenia — 9 reports (5.62%)
  10. Anaemia — 8 reports (5%)

Source database →

ASPARAGINASE ERWINIA CHRYSANTHEMI 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 ASPARAGINASE ERWINIA CHRYSANTHEMI approved in United States?

Yes. FDA authorised it on 30 June 2021.

Who is the marketing authorisation holder for ASPARAGINASE ERWINIA CHRYSANTHEMI in United States?

JAZZ PHARMS holds the US marketing authorisation.