Vadadustat
Vadadustat is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand name including VAFSEO. Available dosage forms: powder, tablet, film coated.
Drug Details
- Generic Name
- Vadadustat
- Brand Names
- VAFSEO
- Application Number
- NDA215192
- Sponsor
- Shanghai SynTheAll Pharmaceutical Co., Ltd.
- NDC Codes
- 5
- Dosage Forms
- POWDER, TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- VADADUSTAT
Indications and Usage
1 INDICATIONS AND USAGE VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being. VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemia In patients with anemia due to CKD not on dialysis [see Warnings and Precautions ( 5.6 )] . VAFSEO is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. ( 1 ) Limitations of Use Not been shown to improve quality of life, fatigue, or patient well-being. Not indicated for use: As a substitute for transfusion in patients requiring immediate correction of anemia. ( 1 ) In patients with anemia due to CKD not on dialysis. ( 1 , 5.6 )