🇺🇸 Zydelig in United States

FDA authorised Zydelig on 23 July 2014 · 1,224 US adverse-event reports

Marketing authorisations

FDA — authorised 23 July 2014

  • Application: NDA205858
  • Marketing authorisation holder: GILEAD SCIENCES INC
  • Status: approved

FDA — authorised 23 July 2014

  • Application: NDA206545
  • Marketing authorisation holder: GILEAD SCIENCES INC
  • Local brand name: ZYDELIG
  • Indication: TABLET — ORAL
  • Status: approved

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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. Diarrhoea — 277 reports (22.63%)
  2. Disease Progression — 178 reports (14.54%)
  3. Off Label Use — 135 reports (11.03%)
  4. Pyrexia — 114 reports (9.31%)
  5. Pneumonia — 98 reports (8.01%)
  6. Pneumonitis — 97 reports (7.92%)
  7. Colitis — 96 reports (7.84%)
  8. Neutropenia — 85 reports (6.94%)
  9. Death — 72 reports (5.88%)
  10. Dehydration — 72 reports (5.88%)

Source database →

Zydelig in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in United States

Frequently asked questions

Is Zydelig approved in United States?

Yes. FDA authorised it on 23 July 2014; FDA authorised it on 23 July 2014; FDA has authorised it.

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

GILEAD SCIENCES INC holds the US marketing authorisation.