← FDA DRUG APPROVALS

FDA NDA · NDA218037

VOYDEYA

danicopan

Sponsor: ALEXION PHARMS INC

APPLICATION
NDA218037
TYPE
NDA
ORIGINAL APPROVAL
2024-03-29
LATEST ACTION
2025-06-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VOYDEYA · ReferencePrescription
DANICOPAN 100MG · TABLET · ORAL
VOYDEYA · ReferencePrescription
DANICOPAN 50MG · TABLET · ORAL

Approval history

2025-06-27REMS · Supplement 4 — Letter ↗AP
2024-03-29Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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