Treats cutaneous manifestations. NDA 21991, held by Msd Sub Merck. Vorinostat.
As of Nov 15, 2026, NDA 21991 (Zolinza), held by Msd Sub Merck, was first approved by FDA on Oct 6, 2006, with 8 approved supplements and 0 published complete response letters.
ZOLINZA is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies.
| Sep 23, 2009 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Oct 6, 2006 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zolinza100MG · capsule;oral | Vorinostat | RxReference drug |
| Dec 11, 2018 | Supplement 9Labeling · Standard review | Approved | |
| Dec 17, 2015 | Supplement 8Labeling · Standard review | Approved | |
| Oct 7, 2015 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Apr 24, 2013 | Supplement 6Labeling · Standard review | Approved | None posted |
| Nov 14, 2011 | Supplement 2Labeling · Standard review | Approved | |
| Jun 10, 2011 | Supplement 5Labeling | Approved | |
| Sep 23, 2009 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jul 22, 2008 | Supplement 1Labeling · Standard review | Approved | |
| Oct 6, 2006 | 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
