MIUDELLA
Miudella is indicated for prevention of pregnancy in females of reproductive potential for up to 3 years. Miudella is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 3 years.( 1 )...
Details
- Status
- Prescription
- First Approved
- 2025-02-24
- Routes
- INTRAUTERINE
- Dosage Forms
- SYSTEM
MIUDELLA Approval History
What MIUDELLA Treats
1 FDA approvalsOriginally approved for its first indication in 2025 .
- Other (1)
MIUDELLA Boxed Warning
RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION Improper insertion of intrauterine systems, including Miudella, increases the risk of complications [see Warnings and Precautions (5.1) ] . Proper training prior to first use of Miudella can minimize the risk of improper Miudella insertion [see Warnings and Precautions (5.1) ]. Miudella is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Miudella REMS program to ensure healthcare provider...
WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION Improper insertion of intrauterine systems, including Miudella, increases the risk of complications [see Warnings and Precautions (5.1) ] . Proper training prior to first use of Miudella can minimize the risk of improper Miudella insertion [see Warnings and Precautions (5.1) ]. Miudella is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Miudella REMS program to ensure healthcare providers are trained on the proper insertion of Miudella prior to first use [see Warnings and Precautions (5.2) ]. WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION Improper insertion of intrauterine systems, including Miudella, increases the risk of complications [see Warnings and Precautions (5.1) ]. Proper training prior to first use of Miudella can minimize the risk of improper Miudella insertion [see Warnings and Precautions (5.1) ]. Miudella is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Miudella REMS program to ensure healthcare providers are trained on the proper insertion of Miudella prior to first use [see Warnings and Precautions (5.2) ].
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.
MIUDELLA FDA Label Details
ProIndications & Usage
FDA Label (PDF)Miudella is indicated for prevention of pregnancy in females of reproductive potential for up to 3 years. Miudella is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 3 years.
WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION Improper insertion of intrauterine systems, including Miudella, increases the risk of complications [see Warnings and Precautions (5.1) ] . Proper training prior to first use of Miudella can minimize the risk of improper Miudella insertion [se...
MIUDELLA Patents & Exclusivity
Patents (13 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.