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Data updated: Jul 17, 2026

MILRINONE LACTATE IN PLASTIC CONTAINER (milrinone lactate) · Hikma

Cardiovascular Approved 2010-01-21

Milrinone Lactate Injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone lactate should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available.

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
16
Years on Market

Details

Status
Prescription
First Approved
2010-01-21
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Hikma
Active Ingredient: MILRINONE LACTATE

MILRINONE LACTATE IN PLASTIC CONTAINER Approval History

2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2010 to 2010
Jan 2010 ORIGINAL
Update

What MILRINONE LACTATE IN PLASTIC CONTAINER Treats

1 indications

MILRINONE LACTATE IN PLASTIC CONTAINER is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.

Source: FDA Label

MILRINONE LACTATE IN PLASTIC CONTAINER Competitive Set

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Indication competitors

10

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

LASIX ONYU
SQ INNOVATION
2025 2 indic.
ENBUMYST
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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.

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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 IN PLASTIC CONTAINER FDA Label Details

Indications & Usage

Milrinone Lactate Injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone lactate should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone lactate has been in patients receiving digoxin and diuretics.

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Data Sources

FDA Approval: ANDA090038 → Label: DailyMed → Trials: ClinicalTrials.gov →

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