FDA-NDA219304
Document details
Summary
Romvimza (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 molecularOral kinase inhibitor Romvimza routes to Part D; no J-code expected.
Affected specialty
Oncology alerts →Source document
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219304s000lbl.pdfCLV Intelligence summarizes publicly available federal publications. Not affiliated with or endorsed by any government agency.
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