Data updated: Mar 10, 2026
FOSAPREPITANT DIMEGLUMINE
FOSAPREPITANT DIMEGLUMINE
Approved 2016-06-09
12
Indications
--
Phase 3 Trials
9
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2016-06-09
- Routes
- INTRAVENOUS, UNKNOWN
- Dosage Forms
- POWDER, UNKNOWN
Companies
ACCORD HLTHCARE MSN CHIA TAI TIANQING PRAXGEN ASPIRO CAPLIN Apotex Teva EUGIA PHARMA GENEYORK PHARMS QILU PHARM HAINAN Viatris Lupin BE PHARMS PIRAMAL CRITICAL Dr. Reddy's Baxter SAGENT PHARMS Fresenius Kabi NAVINTA LLC
Active Ingredient: FOSAPREPITANT DIMEGLUMINE
Website: ↗
FOSAPREPITANT DIMEGLUMINE Approval History
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What FOSAPREPITANT DIMEGLUMINE Treats
12 FDA approvalsOriginally approved for its first indication in 2016 . Covers 12 distinct patient populations.
- Other (12)
Other
(12 approvals)- • Approved indication (Jun 2016)Label Letter
- • Approved indication (Sep 2019)
- • Approved indication (Aug 2020)
- • Approved indication (Aug 2020)
- • Approved indication (Sep 2020)
- • Approved indication (Dec 2020)
- • Approved indication (Dec 2020)
- • Approved indication (Jan 2021)
- • Approved indication (Mar 2021)
- • Approved indication (Jul 2021)
- • Approved indication (Oct 2021)
- • Approved indication (May 2023)
🔬
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.
FOSAPREPITANT DIMEGLUMINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.