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FDA pharmacologic class

CD38-directed Cytolytic Antibody

2 medicines are in FDA's class of cd38-directed cytolytic antibodies: isatuximab (Sarclisa) and daratumumab (Darzalex); 1 combination product also contains one. 0 of the 3 are listed from generic labelers (FDA NDC Directory, October 8, 2026).

Which medicines are cd38-directed cytolytic antibody?

Recalls: FDA enforcement reports, 2012 on
MedicineBrand namesGeneric labelers (all forms)Pharmacy costBoxed warningShortageRecalls since 2012
IsatuximabSarclisanone listedn/aNoNo current entry0
DaratumumabDarzalexnone listedn/aNoNo current entry1
Daratumumab and hyaluronidaseDarzalexnone listedn/aNoNo current entry0

Source: FDA Established Pharmacologic Class (NDC Directory, openFDA); CMS NADAC of October 7, 2026; FDA shortages and recalls (FDA files October 8, 2026)

What next?