FDA — authorised 17 August 2017
- Application: NDA208558
- Marketing authorisation holder: ASTRAZENECA
- Status: supplemented
🇺🇸 Lynparza in United States
FDA authorised Lynparza on 17 August 2017 · 11,086 US adverse-event reports
Marketing authorisations
FDA
- Status: approved
FDA
- Application: ANDA219893
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: OLAPARIB
- Indication: TABLET
- Status: approved
FDA
- Application: ANDA219410
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: OLAPARIB
- Indication: TABLET
- 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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 11,086
Most-reported reactions
- Death — 3,954 reports (35.67%)
- Malignant Neoplasm Progression — 1,488 reports (13.42%)
- Nausea — 1,210 reports (10.91%)
- Anaemia — 1,103 reports (9.95%)
- Fatigue — 1,062 reports (9.58%)
- Off Label Use — 608 reports (5.48%)
- Vomiting — 461 reports (4.16%)
- Drug Ineffective — 453 reports (4.09%)
- Diarrhoea — 388 reports (3.5%)
- Asthenia — 359 reports (3.24%)
Lynparza 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 Lynparza approved in United States?
Yes. FDA authorised it on 17 August 2017; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Lynparza in United States?
ASTRAZENECA holds the US marketing authorisation.