Prevents nausea and vomiting. NDA 22198, held by Apotex. Granisetron.
As of Nov 13, 2026, NDA 22198 (Sancuso), held by Apotex, was first approved by FDA on Sep 12, 2008, with 10 approved supplements and 0 published complete response letters.
SANCUSO is indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 12, 2008 | Original applicationNew active ingredient · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sancuso3.1MG/24HR · film, extended release;transdermal | Granisetron | RxReference drug |
| Sep 16, 2024 | Supplement 23Labeling · Standard review | Approved | |
| Dec 6, 2022 | Supplement 19Manufacturing | Approved | |
| Apr 30, 2020 | Supplement 20Labeling · Standard review | Approved | |
| Sep 13, 2017 | Supplement 16Labeling · Standard review | Approved | |
| Sep 28, 2015 | Supplement 3Labeling | Approved | |
| Sep 18, 2014 | Supplement 12Labeling | Approved | |
| Jul 15, 2014 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Nov 19, 2013 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Feb 14, 2013 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Sep 23, 2011 | Supplement 5Labeling · Standard review | Approved | |
| Sep 12, 2008 | Original applicationNew active ingredient · Standard 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
