Lynparza

Treats deleterious or suspected deleterious germline or … primary peritoneal cancer. NDA 208558, held by Astrazeneca. Olaparib.

As of Nov 14, 2026, NDA 208558 (Lynparza), held by Astrazeneca, was first approved by FDA on Aug 17, 2017, with 21 approved supplements and 0 published complete response letters.

First approved: Aug 17, 2017
Review: Priority
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer

for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.1, 2.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below


Nov 6, 2023	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 31, 2023	Supplement 25Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Aug 26, 2022	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 11, 2022	Supplement 23Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 31, 2022	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 11, 2021	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 7, 2020	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 19, 2020	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 8, 2020	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 27, 2019	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jul 1, 2019	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 19, 2018	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 26, 2018	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 12, 2018	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 17, 2017	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Products

2 strengths and forms


Lynparza100MG · tablet;oral	Olaparib	RxReference drug
Lynparza150MG · tablet;oral	Olaparib	RxReference drug

All 22 submissions, including labeling and manufacturing supplements


Jul 10, 2025	Supplement 31Labeling · Standard review	Approved	Letter Label Medication Guide
Nov 6, 2023	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 12, 2023	Supplement 29Labeling · Standard review	Approved	Letter Label
May 31, 2023	Supplement 25Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Oct 27, 2022	Supplement 24Labeling · Standard review	Approved	Label Letter
Aug 26, 2022	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 11, 2022	Supplement 23Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 31, 2022	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 11, 2021	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 11, 2021	Supplement 20Labeling · Standard review	Approved	Letter Label
Dec 7, 2020	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 2, 2020	Supplement 18Labeling · Standard review	Approved	Letter Label
May 19, 2020	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 8, 2020	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 27, 2019	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Label Letter
Oct 11, 2019	Supplement 12Labeling · Standard review	Approved	Letter
Jul 1, 2019	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 19, 2018	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 26, 2018	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 6, 2018	Supplement 2Labeling · Standard review	Approved	Label
Jan 12, 2018	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 17, 2017	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 208558
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters