TheraRadar
Data updated: May 26, 2026

MILRINONE LACTATE

Cardiovascular Approved 2002-05-28

MILRINONE LACTATE is indicated for the treatment of Heart Failure.

Source: FDA Label • CAPLIN
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
10
Indications
--
Phase 3 Trials
23
Years on Market

Details

Status
Prescription
First Approved
2002-05-28
Routes
INJECTION, Injection
Dosage Forms
INJECTABLE, Injectable

Companies

CAPLIN Baxter Hikma INTL MEDICATED Viatris GLAND PHARMA LTD SHANDONG MEITHEAL Pfizer Fresenius Kabi
Active Ingredient: MILRINONE LACTATE

MILRINONE LACTATE Approval History

2003
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Original
New Indication
New Form
Label Update
29 FDA actions from 2002 to 2025
Jun 2025 SUPPL
Mfg · Manufacturing (CMC)
Jan 2023 ORIGINAL
Update
Apr 2021 ORIGINAL
Update

What MILRINONE LACTATE Treats

1 indications

MILRINONE LACTATE is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Heart Failure
Source: FDA Label

MILRINONE LACTATE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

LASIX ONYU
SQ INNOVATION
2025 2 indic.
ENBUMYST
CORSTASIS THERAP
2025 5 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to MILRINONE LACTATE

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ACTIVASE
ALTEPLASE
1 shared
Roche
Shared indications:
Heart Failure
ADREVIEW
IOBENGUANE SULFATE I-123
1 shared
GE HEALTHCARE
Shared indications:
Heart Failure
ALDACTONE
SPIRONOLACTONE
1 shared
Pfizer
Shared indications:
Heart Failure
View all 20 similar drugs Pro
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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.

MILRINONE LACTATE FDA Label Details

Indications & Usage

FDA Label (PDF)

MILRINONE LACTATE is indicated for the treatment of Heart Failure.

Looking for the branded version?

MILRINONE LACTATE IN PLASTIC CONTAINER

Full clinical data, patents, trials, and competitive landscape for milrinone lactate.

See MILRINONE LACTATE IN PLASTIC CONTAINER

Data Sources

FDA Approval: ANDA214380 → Label: DailyMed → Trials: ClinicalTrials.gov →

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