CMS TransmittalOncology

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

FDA-NDA022437

Document details

Document type
CMS Transmittal
Issuing body
Centers for Medicare & Medicaid Services
Document ID
FDA-NDA022437
Published
July 1, 2026
Effective date
March 10, 2010
MAC region
National

Summary

Trelstar (triptorelin pamoate) is an intramuscular injectable GnRH agonist indicated for advanced prostate cancer, billing under Medicare Part B as a physician-administered drug. As an established inj

IM injectable triptorelin pamoate bills under Medicare Part B.

Affected specialty

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Source document

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022437lbl.pdf

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