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 nameVOXZOGO 0.4mg
Generic nameVOSORITIDE
LabellerBioMarin Pharmaceutical Inc.
Routenot recorded
Label version16
Effective2025-11-25
Retrieved by this site2026-10-03
Full labelhttps://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.

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