vosoritide
vosoritide is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand names including VOXZOGO 0.4mg, VOXZOGO 1.2mg, VOXZOGO 0.56mg. Available dosage form: kit.
Drug Details
- Generic Name
- vosoritide
- Brand Names
- VOXZOGO 0.4mg, VOXZOGO 1.2mg, VOXZOGO 0.56mg
- Application Number
- NDA214938
- Sponsor
- BioMarin Pharmaceutical Inc.
- NDC Codes
- 3
- Dosage Forms
- KIT
- Routes
- N/A
- Active Ingredients
- N/A
Indications and Usage
1 INDICATIONS AND USAGE VOXZOGO is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). VOXZOGO is a C type natriuretic peptide (CNP) analog indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). ( 1 )