Data updated: Mar 10, 2026
PALONOSETRON HYDROCHLORIDE
PALONOSETRON HYDROCHLORIDE
Approved 2015-10-13
13
Indications
--
Phase 3 Trials
10
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2015-10-13
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE, SOLUTION
Companies
AKORN INC SAGENT PHARMS INC Cipla Fresenius Kabi MEITHEAL EUGIA PHARMA Pfizer CHARTWELL RX Dr. Reddy's Novartis Baxter NOVAST LABS Teva Viatris AVET LIFESCIENCES QILU PHARM HAINAN Hikma ACCORD HLTHCARE
Active Ingredient: PALONOSETRON HYDROCHLORIDE
Website: ↗
PALONOSETRON HYDROCHLORIDE Approval History
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What PALONOSETRON HYDROCHLORIDE Treats
13 FDA approvalsOriginally approved for its first indication in 2015 . Covers 13 distinct patient populations.
- Other (13)
Other
(13 approvals)- • Approved indication (Oct 2015)Letter
- • Approved indication (Apr 2016)Letter
- • Approved indication (Aug 2016)Label Letter
- • Approved indication (Nov 2017)Label Letter
- • Approved indication (Mar 2018)Letter
- • Approved indication (Sep 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Dec 2018)Label Letter
- • Approved indication (May 2020)
- • Approved indication (Mar 2021)
- • Approved indication (Jun 2021)
- • Approved indication (Nov 2021)
- • Approved indication (Aug 2023)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PALONOSETRON HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.