SELENIOUS ACID
Details
- Status
- Prescription
- First Approved
- 2019-04-30
- Routes
- INTRAVENOUS, SOLUTION
- Dosage Forms
- SOLUTION, INJECTION
Companies
SELENIOUS ACID Approval History
What SELENIOUS ACID Treats
8 FDA approvalsOriginally approved for its first indication in 2019 . Covers 8 distinct patient populations.
- Other (8)
Other
(8 approvals)- • Approved indication (Apr 2019) PriorityLabel Letter
- • Approved indication (Feb 2025)Letter
- • Approved indication (Feb 2025)
- • Approved indication (Jun 2025) New
- • Approved indication (Jul 2025) New
- • Approved indication (Jul 2025) New
- • Approved indication (Dec 2025) New
- • Approved indication (Feb 2026) New
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
SELENIOUS ACID FDA Label Details
ProIndications & Usage
FDA Label (PDF)Selenious Acid Injection is indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Selenious Acid Injection is a trace element indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
SELENIOUS ACID Patents & Exclusivity
Patents (18 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.