Prevents acute and delayed nausea and vomiting associated with initial and repeat courses…. NDA 210493, held by Helsinn Hlthcare. Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride.
As of Nov 13, 2026, NDA 210493 (Akynzeo), held by Helsinn Hlthcare, was first approved by FDA on Apr 19, 2018, with 5 approved supplements and 0 published complete response letters.
AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. AKYNZEO for injection and
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 19, 2018 | Original applicationNew molecular entity, new combination · Standard review | Approved |
| AkynzeoEQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL · powder;intravenous | Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride | DiscontinuedReference drug |
| AkynzeoEQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML) · solution;intravenous | Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride | RxReference drug |
| Feb 15, 2023 | Supplement 5Labeling · Standard review | Approved | |
| Jun 2, 2021 | Supplement 4Labeling · Standard review | Approved | |
| Oct 27, 2020 | Supplement 3Manufacturing | Approved | |
| May 27, 2020 | Supplement 2Manufacturing | Approved | |
| Feb 24, 2020 | Supplement 1Manufacturing | Approved | None posted |
| Apr 19, 2018 | Original applicationNew molecular entity, new combination · 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
