Quick answers
- What is Letermovir used for?
- The FDA-approved label (Prevymis, Merck Sharp & Dohme LLC, January 14, 2026) says: “PREVYMIS is a CMV DNA terminase complex inhibitor indicated for: Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Letermovir have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Letermovir?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Letermovir been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Letermovir?
- 1 company lists prescription products of Letermovir in the FDA NDC Directory, including Merck Sharp & Dohme LLC.
What Letermovir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PREVYMIS is a CMV DNA terminase complex inhibitor indicated for: Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). …
— FDA label: Prevymis, Merck Sharp & Dohme LLC, effective January 14, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Injection, solution · Pellet |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Prevymis |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Merck Sharp & Dohme LLC6 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA209939 PREVYMIS | Merck Sharp Dohme | November 8, 2017 | 10, latest January 30, 2025 2025: Labeling · 2024: Efficacy · 2024: Efficacy |
| NDA209940 PREVYMIS | Merck Sharp Dohme | November 8, 2017 | 9, latest January 30, 2025 2025: Labeling · 2024: Efficacy · 2024: Efficacy |
| NDA219104 PREVYMIS | Msd | August 30, 2024 | 1, latest January 30, 2025 2025: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Prevymis, Merck Sharp & Dohme LLC, effective January 14, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →