FDA LABEL RECORD
VOXZOGO 0.4mg
VOSORITIDE. FDA prescribing information for this product, as published on the retrieval date below.
AS THE LABEL RECORDS IT
Product details
| Brand name | VOXZOGO 0.4mg |
|---|---|
| Generic name | VOSORITIDE |
| Labeller | BioMarin Pharmaceutical Inc. |
| Route | not recorded |
| Label version | 16 |
| Effective | 2025-11-25 |
| Retrieved by this site | 2026-10-03 |
| Full label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=228e8560-04a4-4bb1-a81f-29531a9e4d27 |
INDICATIONS AND USAGE
Quoted from the FDA label
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 )
What this page is
A reproduction of a public FDA label record. Everything quoted above is the labeller's wording as published by the FDA, not this site's. Nothing here is regulatory, legal or medical advice, and a label being reproduced says nothing about whether a product is available in any particular country. Labels are revised often; the retrieval date above says when this copy was taken, and the full current label is at the link.
WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.