← FDA DRUG APPROVALS

FDA NDA · NDA209939

PREVYMIS

letermovir

Sponsor: MERCK SHARP DOHME

APPLICATION
NDA209939
TYPE
NDA
ORIGINAL APPROVAL
2017-11-08
LATEST ACTION
2025-01-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PREVYMIS · ReferencePrescription
LETERMOVIR 480MG · TABLET · ORAL
PREVYMIS · ReferencePrescription
LETERMOVIR 240MG · TABLET · ORAL

Approval history

2025-01-30Labeling · Supplement 15 · standard — Label ↗AP
2024-08-30Efficacy · Supplement 13 · priority — Label ↗AP
2024-08-30Efficacy · Supplement 16 · priority — Label ↗AP
2023-08-02Efficacy · Supplement 11 · standard — Label ↗AP
2023-06-05Efficacy · Supplement 12 · priority — Letter ↗AP
2023-01-20Manufacturing (CMC) · Supplement 10 — Letter ↗AP
2020-03-23Labeling · Supplement 8 · standard — Label ↗AP
2019-12-20Labeling · Supplement 6 · standard — Label ↗AP
2019-08-29Labeling · Supplement 5 · standard — Label ↗AP
2019-03-05Labeling · Supplement 3 · standard — Letter ↗AP
2017-11-08Type 1 - New Molecular Entity · Original · priority — Letter ↗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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