depemokimab

FDA Drug Profile — Exdensur

Drug Details

Generic Name
depemokimab
Brand Names
Exdensur
Application Number
BLA761458
Sponsor
GlaxoSmithKline LLC
NDC Codes
2
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
DEPEMOKIMAB

Indications and Usage

1 INDICATIONS AND USAGE EXDENSUR is indicated for the add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Limitations of Use EXDENSUR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions ( 5.2 )] . EXDENSUR is an interleukin‑5 (IL-5) antagonist, a monoclonal antibody (humanized immunoglobulin G [IgG]1 kappa) indicated for add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. ( 1 ) Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus. ( 1 )