Zejula

Treats advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. NDA 214876, held by Glaxosmithkline. Niraparib Tosylate.

As of Nov 13, 2026, NDA 214876 (Zejula), held by Glaxosmithkline, was first approved by FDA on Apr 26, 2023, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 26, 2023
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: o a deleterious or suspected deleterious BRCA mutation, and/or o genomic instability. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. ( 1.1, 2.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 18, 2025	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Apr 26, 2023	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

3 strengths and forms

Product	Active ingredient	Marketing
ZejulaEQ 100MG BASE · tablet;oral	Niraparib Tosylate	RxReference drug
ZejulaEQ 200MG BASE · tablet;oral	Niraparib Tosylate	RxReference drug
ZejulaEQ 300MG BASE · tablet;oral	Niraparib Tosylate	RxReference drug

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 27, 2026	Supplement 6Labeling · Standard review	Approved	Letter Label
Jul 18, 2025	Supplement 5Labeling · Standard review	Approved	Letter Label
Jun 18, 2025	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jun 18, 2025	Supplement 4Labeling · Standard review	Approved	Label Letter
Apr 26, 2023	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 214876
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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