Prevents acute and delayed nausea and vomiting associated with initial and repeat courses…. NDA 21372, held by Helsinn Hlthcare. Palonosetron Hydrochloride.
As of Nov 14, 2026, NDA 21372 (Aloxi), held by Helsinn Hlthcare, was first approved by FDA on Jul 25, 2003, with 10 approved supplements and 0 published complete response letters.
Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT 3 ) receptor antagonist indicated in adults for: Moderately emetogenic cancer chemotherapy - prevention of acute and delayed nausea and vomiting associated with initial and repeat courses ( 1.1) Highly emetogenic cancer chemotherapy - prevention of acute nausea and vomiting associated with initial and repeat courses Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.
| May 27, 2014 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| May 27, 2014 | Supplement 19Efficacy (new indication or use) · Priority review | Approved | |
| Feb 29, 2008 | Supplement 8Efficacy (new indication or use) | Approved | |
| Feb 29, 2008 | Supplement 10Efficacy (new indication or use) | Approved | |
| Aug 30, 2007 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jul 25, 2003 | Original applicationNew molecular entity · Standard review | Approved |
| AloxiEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intravenous | Palonosetron Hydrochloride | DiscontinuedReference drug |
| AloxiEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intravenous | Palonosetron Hydrochloride | DiscontinuedReference drug |
| Apr 1, 2020 | Supplement 21Labeling · Standard review | Approved | |
| Sep 18, 2014 | Supplement 20Labeling | Approved | |
| May 27, 2014 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| May 27, 2014 | Supplement 19Efficacy (new indication or use) · Priority review | Approved | |
| Feb 6, 2014 | Supplement 17Labeling · Standard review | Approved | |
| Feb 29, 2008 | Supplement 8Efficacy (new indication or use) | Approved | |
| Feb 29, 2008 | Supplement 10Efficacy (new indication or use) | Approved | |
| Aug 30, 2007 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Aug 23, 2006 | Supplement 5Labeling · Standard review | Approved | |
| Jul 5, 2005 | Supplement 2Labeling · Standard review | Approved | |
| Jul 25, 2003 | Original applicationNew molecular entity · 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
