FDA Approval: ARGATROBAN IN 0.9% SODIUM CHLORIDE (ARGATROBAN) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA206769 · Hematology
CriticalArgatroban in 0.9% Sodium Chloride (NDA206769) is a new intravenous formulation of the established direct thrombin inhibitor argatroban, approved via a Type 5 submission by Teva Pharmaceuticals. As an
View alertFDA Approval: SARCLISA (ISATUXIMAB) — Type 1 - New Molecular Entity
Policy FDA-BLA761113 · Hematology
CriticalSarclisa (isatuximab) is an injectable CD38-directed cytolytic antibody approved for multiple myeloma, administered via intravenous injection and billing under Medicare Part B. As a hospital or office
View alertFDA Approval: BESREMI (ROPEGINTERFERON ALFA-2B) — Type 1 - New Molecular Entity
Policy FDA-BLA761166 · Hematology
CriticalBesremi (ropeginterferon alfa-2b) is a subcutaneously administered injectable approved for polycythemia vera, supporting a Part B billing pathway as a physician-administered drug. As an orphan drug in
View alertFDA Approval: ARGATROBAN (ARGATROBAN) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA209552 · Hematology
HighThe recent FDA approval of Argatroban as an injectable drug suggests it will likely be assigned a J-code for billing under Medicare Part B. Since it is an anticoagulant, providers may receive pass-thr
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