TheraRadar
Data updated: Jun 28, 2026

ERYTHROMYCIN LACTOBIONATE · NEXUS

Infectious Disease Approved 1964-06-25

Erythromycin lactobionate is an injectable antibiotic used when patients have severe infections or cannot take medications by mouth. It treats a variety of bacterial issues, including respiratory tract infections, skin infections, and erythrasma. Doctors often prescribe it to achieve high levels of the drug in the bloodstream quickly, or as an alternative for patients with penicillin sensitivities who have pelvic inflammatory disease.

Source: FDA Label

How ERYTHROMYCIN LACTOBIONATE Works

This drug works by binding to the 50 S ribosomal subunits of susceptible bacteria, which stops the organism from producing necessary proteins. By inhibiting this protein synthesis, the medication prevents the bacteria from growing and spreading. This process specifically targets protein production without affecting the synthesis of nucleic acids.

Source: FDA Label
NDA
Small Molecule
5
Indications
--
Phase 3 Trials
62
Years on Market

Details

Status
Prescription
First Approved
1964-06-25
Routes
INJECTION, Injection
Dosage Forms
INJECTABLE, Injectable

ERYTHROMYCIN LACTOBIONATE Approval History

1990
1991
1992
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1995
1996
1997
1998
1999
2000
2001
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2008
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2026
Original
New Indication
New Form
Label Update
15 FDA actions from 1989 to 2024
Nov 2024 ORIGINAL
Update
Feb 2022 ORIGINAL
Update
Sep 2020 ORIGINAL
Update

What ERYTHROMYCIN LACTOBIONATE Treats

8 indications

ERYTHROMYCIN LACTOBIONATE is approved for 8 conditions since its original approval in 1989. These indications span multiple therapeutic areas including oncology, immunology, and more.

Source: FDA Label

ERYTHROMYCIN LACTOBIONATE Competitive Set

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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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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT02755064 08-008620 UL1TR000135 Ph 1 completed Relationship Between Gastric Emptying and Glycemic Variability in Type 1 Diabetes Mellitus
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Active Pipeline

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Key Completed Trials

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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.

ERYTHROMYCIN LACTOBIONATE FDA Label Details

Indications & Usage

Erythromycin lactobionate for injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below when oral administration is not possible or when the severity of the infection requires immediate high serum levels of erythromycin. Intravenous therapy should be replaced by oral administration at the appropriate time. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci); Streptococcus pneumoniae (Diplococcus pneumoniae); Haemophilus influen...

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ERYTHROCIN

Full clinical data, patents, trials, and competitive landscape for erythromycin lactobionate.

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Data Sources

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