🇺🇸 ABBV-951 in United States

FDA authorised ABBV-951 on 16 October 2024 · 3 US adverse-event reports

Marketing authorisation

FDA — authorised 16 October 2024

• Application: NDA216962
• Marketing authorisation holder: ABBVIE
• Local brand name: VYALEV
• Indication: SOLUTION — SUBCUTANEOUS
• Status: approved

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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: 22 April 2025 – 22 April 2026
• Total reports: 3

Most-reported reactions

1. Papillary Thyroid Cancer — 1 report (33.33%)
2. Prostate Cancer — 1 report (33.33%)
3. Psychotic Disorder — 1 report (33.33%)

Source database →

Frequently asked questions

Is ABBV-951 approved in United States?

Yes. FDA authorised it on 16 October 2024.

Who is the marketing authorisation holder for ABBV-951 in United States?

ABBVIE holds the US marketing authorisation.