FDA · United States
erythromycin — FDA regulatory status
erythromycin (MAYNE PHARMA ERYTHROMYCIN) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- MAYNE PHARMA ERYTHROMYCIN
- Originator
- Amneal Pharma Europe Ltd
- Mechanism
- Bacterial 70S ribosome inhibitor
- Target
- Bacterial 70S ribosome
- Structured fields
- 8
Sponsor / originator context: Amneal Pharma Europe Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Bacterial 70S ribosome inhibitor. Target: Bacterial 70S ribosome. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 25 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| ASND0047 | Phase 3 | Ascendis Pharma | 2025-523079-44-00 |
| EIK1001-006 | Phase 3 | Eikon Therapeutics | 2024-512659-19-00 |
| Irinotecan liposome、5-Fluorouracil、Leucovorin | Phase 3 | LianBio | NCT05074589 |
| MT-3-01 | Phase 3 | Minoryx Therapeutics | 2024-515104-39-00 |
| NN8640-4467 | Phase 3 | NovoThirteen | 2023-506927-27-00 |
| Ustekinumab Dose Based on BSA and Body Weight | Phase 3 | Janssen Cilag International | NCT04630028 |
| 111-210 | Phase 2 | BioMarin Pharmaceutical Australia | 2024-520137-74-00 |
| 111-211 | Phase 2 | BioMarin Pharmaceutical Australia | 2024-515861-33-00 |
| ASCAPE-based follow-up strategy | Phase 2 | ATOSSA THERAPEUTICS | NCT04879563 |
| EIK1001-008 | Phase 2 | Eikon Therapeutics | 2025-525013-23-00 |
| FINGER 2.0 multidomain lifestyle-based intervention | Phase 2 | BRIGHT MINDS BIOSCIENCES | NCT05109169 |
| IB 2019-01 | Phase 2 | George Institute for | 2023-509492-16-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2025172818 | POLYTHÉRAPIE À BASE DE PYRILUTAMIDE | WO |
| 12370255 | Peptide-based vaccines, methods of manufacturing, and uses thereof for inducing an immune response | US |
| 12365659 | Non-polyamine based polyamine transport inhibitors and their use in the treatment of human cancers | US |
| 12343424 | Photochemically stable, non-leaching, bridged polysilsesquioxane based sunscreens | US |
| 12311054 | Compositions and methods of using propylene sulfide-based polymers for treatment of Chagas disease | US |
| 12281056 | Methods for making and using endoxifen | US |
| 12275684 | Methods for making and using endoxifen | US |
| 12264366 | Genome-based methods for reducing cardiovascular risk | US |
| 12233103 | Indoleamine 2,3-dioxygenase based immunotherapy | US |
| 12201591 | Sustained release compositions of endoxifen | US |
| 12144877 | Graphene-based multifunctional cosmetic compositions | US |
| 12133884 | Methods of substituting pathogenic amino acids using programmable base editor systems | US |
Related hubs
FAQ
What is the FDA approval status of erythromycin?
erythromycin currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get erythromycin regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to erythromycin?
This spoke lists 25 published programs associated with erythromycin in our pipeline index.