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FDA NDA · NDA209940

PREVYMIS

letermovir

Sponsor: MERCK SHARP DOHME

APPLICATION
NDA209940
TYPE
NDA
ORIGINAL APPROVAL
2017-11-08
LATEST ACTION
2025-01-30
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

PREVYMIS · ReferencePrescription
LETERMOVIR 240MG/12ML (20MG/ML) · SOLUTION · INTRAVENOUS
PREVYMIS · ReferencePrescription
LETERMOVIR 480MG/24ML (20MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-01-30Labeling · Supplement 15 · standard — Label ↗AP
2024-08-30Efficacy · Supplement 16 · priority — Label ↗AP
2024-08-30Efficacy · Supplement 12 · priority — Label ↗AP
2023-08-02Efficacy · Supplement 10 · standard — Letter ↗AP
2023-06-05Efficacy · Supplement 11 · priority — Label ↗AP
2020-03-23Labeling · Supplement 6 · standard — Label ↗AP
2019-12-20Labeling · Supplement 4 · standard — Label ↗AP
2019-08-29Labeling · Supplement 3 · standard — Label ↗AP
2019-03-05Labeling · Supplement 1 · standard — Letter ↗AP
2017-11-08Type 3 - New Dosage Form · 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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