Prevents cytomegalovirus (CMV) infection and disease. NDA 209940, held by Merck Sharp Dohme. Letermovir.
As of Nov 13, 2026, NDA 209940 (Prevymis), held by Merck Sharp Dohme, was first approved by FDA on Nov 8, 2017, with 9 approved supplements and 0 published complete response letters.
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). Prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]). 1.
| Aug 30, 2024 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Aug 30, 2024 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Aug 2, 2023 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jun 5, 2023 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Nov 8, 2017 | Original applicationNew dosage form · Priority review | Approved |
| Prevymis240MG/12ML (20MG/ML) · solution;intravenous | Letermovir | RxReference drug |
| Prevymis480MG/24ML (20MG/ML) · solution;intravenous | Letermovir | RxReference drug |
| Jan 30, 2025 | Supplement 15Labeling · Standard review | Approved | |
| Aug 30, 2024 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Aug 30, 2024 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Aug 2, 2023 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jun 5, 2023 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Mar 23, 2020 | Supplement 6Labeling · Standard review | Approved | |
| Dec 20, 2019 | Supplement 4Labeling · Standard review | Approved | |
| Aug 29, 2019 | Supplement 3Labeling · Standard review | Approved | |
| Mar 5, 2019 | Supplement 1Labeling · Standard review | Approved | |
| Nov 8, 2017 | Original applicationNew dosage form · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
