FDA — authorised 19 November 2021
- Application: NDA214938
- Marketing authorisation holder: BIOMARIN PHARM
- Local brand name: VOXZOGO
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
🇺🇸 VOSORITIDE in United States
FDA authorised VOSORITIDE on 19 November 2021 · 3 US adverse-event reports
Marketing authorisation
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 3
Most-reported reactions
- Dose Calculation Error — 1 report (33.33%)
- Product Preparation Error — 1 report (33.33%)
- Product Prescribing Error — 1 report (33.33%)
VOSORITIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is VOSORITIDE approved in United States?
Yes. FDA authorised it on 19 November 2021.
Who is the marketing authorisation holder for VOSORITIDE in United States?
BIOMARIN PHARM holds the US marketing authorisation.