← FDA DRUG APPROVALS

FDA NDA · NDA217779

RYTELO

imetelstat sodium

Sponsor: GERON

APPLICATION
NDA217779
TYPE
NDA
ORIGINAL APPROVAL
2024-06-06
LATEST ACTION
2026-04-14
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

RYTELO · ReferencePrescription
IMETELSTAT SODIUM EQ 47MG BASE/VIAL · POWDER · INTRAVENOUS
RYTELO · ReferencePrescription
IMETELSTAT SODIUM EQ 188MG BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2026-04-14Labeling · Supplement 6 · standard — Letter ↗AP
2024-06-06Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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