NDA 209296, held by Heron Theraps Inc. Aprepitant.
As of Nov 13, 2026, NDA 209296 (Cinvanti), held by Heron Theraps Inc, was first approved by FDA on Nov 9, 2017, with 4 approved supplements and 0 published complete response letters.
CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen. nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 21, 2019 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Feb 26, 2019 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Nov 9, 2017 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cinvanti130MG/18ML (7.2MG/ML) · emulsion;intravenous | Aprepitant | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 5, 2024 | Supplement 15Labeling · Standard review | Approved | |
| Mar 14, 2022 | Supplement 8Manufacturing | Approved | |
| Oct 21, 2019 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Feb 26, 2019 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Nov 9, 2017 | Original applicationNew dosage form · 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
