enzalutamide
Drug Details
- Generic Name
- enzalutamide
- Brand Names
- Xtandi
- Application Number
- NDA213674
- Sponsor
- Astellas Pharma US, Inc.
- NDC Codes
- 9
- Dosage Forms
- TABLET, POWDER, CAPSULE
- 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 )