← FDA DRUG APPROVALS

FDA NDA · NDA213246

RETEVMO

selpercatinib

Sponsor: ELI LILLY AND CO

APPLICATION
NDA213246
TYPE
NDA
ORIGINAL APPROVAL
2020-05-08
LATEST ACTION
2026-07-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

RETEVMO · ReferencePrescription
SELPERCATINIB 40MG · CAPSULE · ORAL
RETEVMO · ReferencePrescription
SELPERCATINIB 80MG · CAPSULE · ORAL

Approval history

2026-07-14Efficacy · Supplement 17 · standard — Letter ↗AP
2025-11-20Efficacy · Supplement 15 · priority — Letter ↗AP
2025-11-20Labeling · Supplement 16 · standard — Letter ↗AP
2024-12-18Labeling · Supplement 14 · standard — Label ↗AP
2024-09-27Efficacy · Supplement 13 · priority — Label ↗AP
2024-09-27Efficacy · Supplement 11 · standard — Label ↗AP
2024-06-12Efficacy · Supplement 9 · standard — Label ↗AP
2024-05-29Efficacy · Supplement 12 · priority — Label ↗AP
2024-04-10Labeling · Supplement 10 · standard — Label ↗AP
2022-09-21Efficacy · Supplement 7 · standard — Letter ↗AP
2022-09-21Efficacy · Supplement 8 · priority — Letter ↗AP
2021-01-28Labeling · Supplement 2 · standard — Letter ↗AP
2020-05-08Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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