FDA BLA · BLA761432

ENFLONSIA

Sponsor: MERCK SHARP DOHME

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APPLICATION
BLA761432
TYPE
BLA
ORIGINAL APPROVAL
2025-06-09
LATEST ACTION
2026-10-14
ROUTE
SOLUTION
DOSAGE FORM
INJECTION
MARKETING STATUS
Prescription

Products

ENFLONSIAPrescription
CLESROVIMAB-CFOR 105MG/0.7ML · INJECTION · SOLUTION

Approval history

2026-10-14Efficacy · Supplement 3 · standard — Letter ↗AP
2025-06-09Type 1 - New Molecular Entity · Original · priority — Letter ↗AP