Xtandi

NDA 213674, held by Astellas. Enzalutamide.

As of Nov 13, 2026, NDA 213674 (Xtandi), held by Astellas, was first approved by FDA on Aug 4, 2020, with 8 approved supplements and 0 published complete response letters.

First approved: Aug 4, 2020
Review: Standard
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

XTANDI is indicated for the treatment of patients with:

castration-resistant prostate cancer (CRPC)
metastatic castration-sensitive prostate cancer (mCSPC)
non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR)

Full prescribing information on DailyMed ↗

Approvals and New Uses

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


Jul 24, 2026	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 16, 2023	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Label Letter
Sep 9, 2022	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 4, 2020	Original applicationNew dosage form · Standard review	Approved	Review Label

Products

2 strengths and forms


Xtandi40MG · tablet;oral	Enzalutamide	RxReference drug
Xtandi80MG · tablet;oral	Enzalutamide	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Jul 24, 2026	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 11, 2025	Supplement 15Labeling · Standard review	Approved	Label Letter
Mar 21, 2025	Supplement 12Labeling · Standard review	Approved	Letter Label
Jan 22, 2025	Supplement 11Labeling · Standard review	Approved	Label Letter
Nov 16, 2023	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Label Letter
Sep 9, 2022	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 13, 2022	Supplement 5Labeling · Standard review	Approved	Label Letter
May 24, 2021	Supplement 2Labeling · Standard review	Approved	Label Letter
Aug 4, 2020	Original applicationNew dosage form · Standard review	Approved	Review Label

Identifiers

Application: NDA 213674
Drugs@FDA: Overview at FDA
Company: Astellas Pharma

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