Prevents acute and delayed nausea and vomiting associated with initial and repeat courses…. NDA 22445, held by Heron Theraps Inc. Granisetron.
As of Nov 14, 2026, NDA 22445 (Sustol), held by Heron Theraps Inc, was first approved by FDA on Aug 9, 2016, with 2 approved supplements and 0 published complete response letters.
SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 9, 2016 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sustol10MG/0.4ML (10MG/0.4ML) · injectable;subcutaneous | Granisetron | DiscontinuedReference drug |
| Feb 23, 2026 | Supplement 14Labeling · Standard review | Approved | |
| May 25, 2023 | Supplement 10Labeling · Standard review | Approved | |
| Aug 9, 2016 | Original applicationNew formulation or manufacturer · 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
