Treats post-transplant cytomegalovirus (CMV) infection/disease. NDA 215596, held by Takeda Pharms USA. Maribavir.
As of Nov 13, 2026, NDA 215596 (Livtencity), held by Takeda Pharms USA, was first approved by FDA on Nov 23, 2021, with 5 approved supplements and 0 published complete response letters.
LIVTENCITY is indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 21, 2025 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Nov 23, 2021 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Livtencity200MG · tablet;oral | Maribavir | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 21, 2025 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Mar 22, 2024 | Supplement 5Labeling · Standard review | Approved | |
| Apr 26, 2023 | Supplement 4Labeling · Standard review | Approved | |
| Sep 8, 2022 | Supplement 3Labeling · Standard review | Approved | |
| Jan 18, 2022 | Supplement 1Labeling · Standard review | Approved | |
| Nov 23, 2021 | Original applicationNew molecular entity · 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
