TheraRadar
Data updated: Mar 29, 2026

PHOSLYRA

CALCIUM ACETATE
Approved 2011-04-18
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
14
Years on Market

Details

Status
Discontinued
First Approved
2011-04-18
Routes
ORAL
Dosage Forms
SOLUTION

Companies

Fresenius Kabi
Active Ingredient: CALCIUM ACETATE

PHOSLYRA Approval History

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What PHOSLYRA Treats

1 FDA approvals

Originally approved for its first indication in 2011 .

  • Other (1)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

PHOSLYRA FDA Label Details

Pro

PHOSLYRA Patents & Exclusivity

Latest Patent: Feb 2030

Patents (3 active)

US8591938 Expires Feb 23, 2030
US8592480 Expires Jul 20, 2027
US9089528 Expires Jul 20, 2027
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA022581 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.