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FDA NDA · NDA214938

VOXZOGO 0.4MG

vosoritide

Sponsor: BIOMARIN PHARM

APPLICATION
NDA214938
TYPE
NDA
ORIGINAL APPROVAL
2021-11-19
LATEST ACTION
2024-11-04
ROUTE
SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

VOXZOGO · ReferencePrescription
VOSORITIDE 0.56MG/VIAL · POWDER · SUBCUTANEOUS
VOXZOGO · ReferencePrescription
VOSORITIDE 1.2MG/VIAL · POWDER · SUBCUTANEOUS
VOXZOGO · ReferencePrescription
VOSORITIDE 0.4MG/VIAL · POWDER · SUBCUTANEOUS

Approval history

2024-11-04Labeling · Supplement 4 · standard — Label ↗AP
2023-10-20Efficacy · Supplement 2 · standard — Label ↗AP
2021-11-19Type 1 - New Molecular Entity · Original · standard — Label ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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