CMS TransmittalOncology

FDA Approval: TRELSTAR (TRIPTORELIN PAMOATE) — Type 3 - New Dosage Form

FDA-NDA021288

Document details

Document type
CMS Transmittal
Issuing body
Centers for Medicare & Medicaid Services
Document ID
FDA-NDA021288
Published
July 1, 2026
Effective date
June 29, 2001
MAC region
National

Summary

Trelstar (triptorelin pamoate) is an intramuscular injectable approved for a new dosage form under NDA021288, placing it firmly in the Medicare Part B billing pathway as a physician-administered drug.

IM injectable Trelstar falls under Part B; verify J-code by dose.

Affected specialty

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Source document

http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21288lbl.pdf

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