Prevents postoperative nausea and vomiting (PONV). NDA 216457, held by Heron Theraps Inc. Aprepitant.
As of Nov 13, 2026, NDA 216457 (Aponvie), held by Heron Theraps Inc, was first approved by FDA on Sep 16, 2022, with 1 approved supplement and 0 published complete response letters.
APONVIE is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 16, 2022 | Original applicationNew indication · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aponvie32MG/4.4ML (7.2MG/ML) · emulsion;intravenous | Aprepitant | RxReference drug |
| Mar 5, 2024 | Supplement 3Labeling · Standard review | Approved | |
| Sep 16, 2022 | Original applicationNew indication · 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
