Quick answers
- What is Enzalutamide used for?
- The FDA-approved label (Xtandi, Astellas Pharma US, Inc., July 28, 2026) says: “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) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Enzalutamide 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 Enzalutamide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Enzalutamide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Enzalutamide?
- 1 company lists prescription products of Enzalutamide in the FDA NDC Directory, including Astellas Pharma US, Inc..
What Enzalutamide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with …
— FDA label: Xtandi, Astellas Pharma US, Inc., effective July 28, 2026. 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 · Capsule |
|---|---|
| Route | Oral |
| Prescription products | 5 in the FDA NDC Directory |
| Brand names | Xtandi |
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.
- Astellas Pharma US, Inc.5 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA203415 XTANDI | Astellas | August 31, 2012 | 20, latest July 24, 2026 2026: Efficacy · 2025: Labeling · 2025: Labeling |
| NDA213674 XTANDI | Astellas | August 4, 2020 | 8, latest July 24, 2026 2026: Efficacy · 2025: Labeling · 2025: 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Xtandi, Astellas Pharma US, Inc., effective July 28, 2026; 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 →