Treats chorea associated with Huntington's disease. NDA 21894, held by Bausch. Tetrabenazine.
As of Nov 15, 2026, NDA 21894 (Xenazine), held by Bausch, was first approved by FDA on Aug 15, 2008, with 9 approved supplements and 0 published complete response letters.
Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington's disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 15, 2008 | Original applicationNew molecular entity · Priority review | Approved |
| Xenazine12.5MG · tablet;oral | Tetrabenazine | RxReference drug |
| Xenazine25MG · tablet;oral | Tetrabenazine | RxReference drug |
| Sep 13, 2017 | Supplement 13Labeling · Standard review | Approved | |
| Aug 25, 2015 | Supplement 12REMS | Approved | |
| Jun 3, 2015 | Supplement 10Labeling · Standard review | Approved | |
| Aug 2, 2013 | Supplement 9REMS | Approved | |
| Aug 17, 2012 | Supplement 7REMS | Approved | |
| Jul 6, 2011 | Supplement 4Labeling · Standard review | Approved | |
| May 4, 2011 | Supplement 5Labeling · Standard review | Approved | |
| Dec 1, 2009 | Supplement 2Labeling · Standard review | Approved | |
| Dec 1, 2009 | Supplement 1Labeling · Standard review | Approved | |
| Aug 15, 2008 | 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
