darolutamide
Drug Details
- Generic Name
- darolutamide
- Brand Names
- NUBEQA
- Application Number
- NDA212099
- Sponsor
- Orion Corporation, ORION PHARMA
- NDC Codes
- 2
- Dosage Forms
- TABLET, TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- DAROLUTAMIDE
Indications and Usage
1 INDICATIONS AND USAGE NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. ( 1 ) NUBEQA is indicated for the treatment of adult patients with: non-metastatic castration resistant prostate cancer (nmCRPC) metastatic castration-sensitive prostate cancer (mCSPC) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.