METHYLERGONOVINE MALEATE · GRANULES
Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.
Details
- Status
- Prescription
- First Approved
- 1946-11-19
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
METHYLERGONOVINE MALEATE Approval History
What METHYLERGONOVINE MALEATE Treats
3 indicationsMETHYLERGONOVINE MALEATE is approved for 3 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Uterine Atony
- Hemorrhage
- Subinvolution of the Uterus
METHYLERGONOVINE MALEATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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 METHYLERGONOVINE MALEATE
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03584854 results posted | 2018P000775-A | Ph 4 | completed | Second-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
METHYLERGONOVINE MALEATE FDA Label Details
Indications & Usage
FDA Label (PDF)Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.
Looking for the branded version?
METHERGINE
Full clinical data, patents, trials, and competitive landscape for methylergonovine maleate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.