CMS TransmittalGastroenterology

FDA Approval: TERLIVAZ (TERLIPRESSIN) — Type 1 - New Molecular Entity

FDA-NDA022231

Document details

Document type: CMS Transmittal
Issuing body: Centers for Medicare & Medicaid Services
Document ID: FDA-NDA022231
Published: June 13, 2026
Effective date: September 14, 2022
MAC region: National

Summary

Terlivaz (terlipressin) is an injectable medication, likely to receive an assigned J-code for billing under Medicare Part B. Given its status as an orphan drug, it may qualify for pass-through payment

New injectable terlipressin approved for Medicare billing.

Affected specialty

Gastroenterology alerts →

Source document

http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022231s000lbl.pdf

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