Rubraca

Treats a deleterious BRCA mutation (germline and/or … primary peritoneal cancer. NDA 209115, held by Pharmaand. Rucaparib Camsylate.

As of Nov 14, 2026, NDA 209115 (Rubraca), held by Pharmaand, was first approved by FDA on Dec 19, 2016, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 19, 2016
Review: Priority
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Prostate cancer for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA. ( 1.2, 2.1 ) 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below


Dec 17, 2025	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 17, 2025	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 21, 2022	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 10, 2022	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Label Letter
Oct 8, 2020	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 15, 2020	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 6, 2018	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 19, 2016	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

3 strengths and forms


RubracaEQ 200MG BASE · tablet;oral	Rucaparib Camsylate	RxReference drug
RubracaEQ 300MG BASE · tablet;oral	Rucaparib Camsylate	RxReference drug
RubracaEQ 250MG BASE · tablet;oral	Rucaparib Camsylate	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Dec 17, 2025	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 17, 2025	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 21, 2022	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 10, 2022	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Label Letter
Sep 30, 2021	Supplement 9Labeling · Standard review	Approved	Letter Label
Oct 8, 2020	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 15, 2020	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 6, 2018	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 19, 2016	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 209115
Drugs@FDA: Overview at FDA
Company: Pharmaand GmbH

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