Quick answers
- What is Olaparib used for?
- The FDA-approved label (Lynparza, AstraZeneca Pharmaceuticals LP, July 10, 2025) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Olaparib have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Olaparib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Olaparib been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Olaparib?
- 1 company lists prescription products of Olaparib in the FDA NDC Directory, including AstraZeneca Pharmaceuticals LP.
What Olaparib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Lynparza, AstraZeneca Pharmaceuticals LP, effective July 10, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Lynparza |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- AstraZeneca Pharmaceuticals LP4 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA208558 LYNPARZA | Astrazeneca | August 17, 2017 | 21, latest July 10, 2025 2025: Labeling · 2023: Efficacy · 2023: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1942482, 1942485, 1942487, 1942489 |
|---|---|
| SPL set ID of the quoted label | 741ff3e3-dc1a-45a6-84e5-2481b27131aa |
| FDA labels (SPL) | 1 |
| FDA applications | NDA208558 |
| Active ingredients (FDA) | OLAPARIB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lynparza, AstraZeneca Pharmaceuticals LP, effective July 10, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →