FDA Approval: TRELSTAR (TRIPTORELIN PAMOATE) — Type 3 - New Dosage Form
Policy FDA-NDA022437 · Oncology
CriticalTrelstar (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
View alertFDA Approval: TRELSTAR (TRIPTORELIN PAMOATE) — Type 1 - New Molecular Entity
Policy FDA-NDA020715 · Oncology
CriticalTrelstar (triptorelin pamoate) is an intramuscular injectable indicated for prostate cancer, placing it squarely in the Medicare Part B billing pathway as a physician-administered drug. It is typicall
View alertFDA Approval: ROMVIMZA (VIMSELTINIB) — Type 1 - New Molecular Entity
Policy FDA-NDA219304 · Oncology
HighRomvimza (vimseltinib) is an oral capsule kinase inhibitor approved via NDA219304, placing it squarely in the Medicare Part D billing pathway as a self-administered outpatient drug. As a new molecular
View alertFDA Approval: NAVITRUX (FOSAPREPITANT) — Type 5 - New Formulation or New Manufacturer
Policy FDA-NDA220436 · Oncology
CriticalNAVITRUX (fosaprepitant) is a new intravenous formulation of fosaprepitant dimeglumine approved under NDA220436 as a Type 5 submission, indicating a new formulation or manufacturer rather than a novel
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