enzalutamide

FDA Drug Profile — Xtandi

enzalutamide is listed in the FDA National Drug Code directory with 14 NDC codes, marketed under brand name including Xtandi. Available dosage forms: tablet, capsule, powder.

Drug Details

Generic Name
enzalutamide
Brand Names
Xtandi
Application Number
NDA213674
Sponsor
Astellas Pharma US, Inc.
NDC Codes
14
Dosage Forms
TABLET, CAPSULE, POWDER
Routes
ORAL
Active Ingredients
ENZALUTAMIDE

Indications and Usage

1 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) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with: • castration-resistant prostate cancer. ( 1 ) • metastatic castration-sensitive prostate cancer. ( 1 ) • non‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis. ( 1 )