Treats CMV retinitis. NDA 22257, held by Cheplapharm. Valganciclovir Hydrochloride.
As of Nov 14, 2026, NDA 22257 (Valcyte), held by Cheplapharm, was first approved by FDA on Aug 28, 2009, with 9 approved supplements and 0 published complete response letters.
VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk. Pediatric Patients Prevention of CMV disease in kidney and heart transplant patients at high risk. 1.1 Adult Patients Treatment of Cytomegalovirus (CMV) Retinitis: VALCYTE is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).
| Aug 2, 2018 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Apr 23, 2015 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Aug 28, 2009 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Valcyte50MG/ML · for solution;oral | Valganciclovir Hydrochloride | RxReference drug |
| Dec 23, 2021 | Supplement 12Labeling · Standard review | Approved | |
| Nov 24, 2020 | Supplement 11Labeling · Standard review | Approved | |
| Oct 21, 2020 | Supplement 10Manufacturing | Approved | |
| Aug 2, 2018 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Jun 22, 2017 | Supplement 7Labeling · Standard review | Approved | |
| Jul 14, 2015 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Apr 23, 2015 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Mar 28, 2013 | Supplement 4Labeling · Standard review | Approved | |
| Aug 5, 2010 | Supplement 3Labeling | Approved | |
| Aug 28, 2009 | 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
