enzalutamide

FDA Drug Profile — Xtandi

enzalutamide is listed in the FDA National Drug Code directory with 9 NDC codes, marketed under brand name including Xtandi. Available dosage forms: powder, capsule, tablet.

Drug Details

Generic Name
enzalutamide
Brand Names
Xtandi
Application Number
NDA203415
Sponsor
Lonza Bend Inc
NDC Codes
9
Dosage Forms
POWDER, CAPSULE, TABLET
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 )