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FDA NDA · NDA216962

VYALEV

foscarbidopa/foslevodopa

Sponsor: ABBVIE

APPLICATION
NDA216962
TYPE
NDA
ORIGINAL APPROVAL
2024-10-16
LATEST ACTION
2026-03-19
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

VYALEV · ReferencePrescription
FOSCARBIDOPA 120MG/10ML, FOSLEVODOPA 2400MG/10ML (12MG/ML · SOLUTION · SUBCUTANEOUS

Approval history

2026-03-19Labeling · Supplement 7 · standard — Letter ↗AP
2024-10-16Type 3 - New Dosage Form and Type 4 - New Combination · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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