CMS TransmittalHematology

FDA Approval: ARGATROBAN (ARGATROBAN) — Type 5 - New Formulation or New Manufacturer

FDA-NDA209552

Document details

Document type
CMS Transmittal
Issuing body
Centers for Medicare & Medicaid Services
Document ID
FDA-NDA209552
Published
June 13, 2026
Effective date
November 27, 2018
MAC region
National

Summary

The 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

New injectable anticoagulant Argatroban now available for Medicare billing.

Affected specialty

Hematology alerts →

Source document

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209552Orig1s000ltr.pdf

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