Treats metastatic pancreatic adenocarcinoma. NDA 207793, held by Ipsen. Irinotecan Hydrochloride.
As of Nov 14, 2026, NDA 207793 (Onivyde), held by Ipsen, was first approved by FDA on Oct 22, 2015, with 3 approved supplements and 0 published complete response letters.
ONIVYDE is indicated, in combination with oxaliplatin, fluorouracil and leucovorin for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma. ONIVYDE is indicated, in combination with fluorouracil and leucovorin, for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy. Limitations of Use: ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic pancreatic adenocarcinoma..
| Feb 13, 2024 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Oct 22, 2015 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| OnivydeEQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) · injectable, liposomal;intravenous | Irinotecan Hydrochloride | RxReference drug |
| Dec 23, 2024 | Supplement 18Labeling · Standard review | Approved | |
| Feb 13, 2024 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Feb 3, 2023 | Supplement 15Labeling · Standard review | Approved | |
| Oct 22, 2015 | Original applicationNew formulation or manufacturer · Priority 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
