🇺🇸 Pegfilgrastim-Cbqv in United States

FDA authorised Pegfilgrastim-Cbqv on 2 November 2018 · 16 US adverse-event reports

Marketing authorisation

FDA — authorised 2 November 2018

  • Application: BLA761039
  • Marketing authorisation holder: COHERUS BIOSCIENCES INC
  • Local brand name: UDENYCA
  • Indication: INJECTABLE — INJECTION
  • 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. Dyspnoea — 2 reports (12.5%)
  2. Embolism — 2 reports (12.5%)
  3. Febrile Neutropenia — 2 reports (12.5%)
  4. Malaise — 2 reports (12.5%)
  5. Neutropenia — 2 reports (12.5%)
  6. Pneumonitis — 2 reports (12.5%)
  7. Abdominal Pain Upper — 1 report (6.25%)
  8. Acute Kidney Injury — 1 report (6.25%)
  9. Acute Respiratory Failure — 1 report (6.25%)
  10. Application Site Erythema — 1 report (6.25%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is Pegfilgrastim-Cbqv approved in United States?

Yes. FDA authorised it on 2 November 2018.

Who is the marketing authorisation holder for Pegfilgrastim-Cbqv in United States?

COHERUS BIOSCIENCES INC holds the US marketing authorisation.