Data updated: Mar 10, 2026
NOXAFIL
POSACONAZOLE
Approved 2006-09-15
7
Indications
--
Phase 3 Trials
2
Priority Reviews
19
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2006-09-15
- Routes
- INTRAVENOUS, ORAL
- Dosage Forms
- SOLUTION, TABLET, DELAYED RELEASE, SUSPENSION
NOXAFIL Approval History
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What NOXAFIL Treats
7 FDA approvalsOriginally approved for its first indication in 2006 . Covers 7 distinct patient populations.
- Other (7)
Other
(7 approvals)- • Approved indication (Sep 2006) PriorityLabel Letter
- • Approved indication (Oct 2006)Label Letter
- • Approved indication (Nov 2013)Label Letter
- • Approved indication (Mar 2014) PriorityLabel Letter
- • Approved indication (May 2021)Label Letter
- • Approved indication (Jun 2021)Label Letter
- • Approved indication (Jan 2026) NewLabel Letter
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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.
NOXAFIL FDA Label Details
ProNOXAFIL Patents & Exclusivity
Latest Patent: Feb 2033
Exclusivity: Jun 2028
Patents (9 active)
Exclusivity
ODE-355
Until Jun 2028
ODE-355
Until Jun 2028
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.