voxelotor
Drug Details
- Generic Name
- voxelotor
- Brand Names
- N/A
- Application Number
- Sponsor
- Patheon Inc.
- NDC Codes
- 1
- Dosage Forms
- TABLET, FOR SUSPENSION
- Routes
- N/A
- Active Ingredients
- VOXELOTOR
Indications and Usage
1 INDICATIONS AND USAGE OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older. This indication is approved under accelerated approval based on increase in hemoglobin (Hb) [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). OXBRYTA is a hemoglobin S polymerization inhibitor indicated for the treatment of sickle cell disease in adults and pediatric patients 4 years of age and older. This indication is approved under accelerated approval based on increase in hemoglobin (Hb). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). ( 1 )