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FDA Medication Tracker

← All approvals · Infections & vaccines · 2025

Enflonsia (clesrovimab-cfor)

The FDA approved Enflonsia (clesrovimab-cfor) on June 9, 2025 to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season.
Brand name
Enflonsia
Generic name
clesrovimab-cfor
FDA approval date
June 9, 2025
Approved use (FDA wording)
To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season
Company
Merck Sharp Dohme
Application
BLA761432
Dosage form / route
INJECTION · SOLUTION
Drug class (EPC)
Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]
Boxed warning on label
Not listed
Category on this site
Infections & vaccines

Indications and usage, from the FDA label

ENFLONSIA is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. ENFLONSIA is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.