ETHINYL ESTRADIOL AND NORELGESTROMIN (ethinyl estradiol)
A weekly contraceptive patch that delivers two hormones transdermally for pregnancy prevention. The transdermal delivery method results in greater systemic estrogen exposure compared to oral pills with similar hormone content. Marketed under brand names Ortho Evra and Xulane.
How ETHINYL ESTRADIOL AND NORELGESTROMIN Works
Hormones absorbed through the skin suppress the monthly maturation of eggs, blocking the ovulation process necessary for conception.
Details
- Status
- Prescription
- First Approved
- 2021-02-25
- Routes
- TRANSDERMAL
- Dosage Forms
- FILM, EXTENDED RELEASE
ETHINYL ESTRADIOL AND NORELGESTROMIN Approval History
What ETHINYL ESTRADIOL AND NORELGESTROMIN Treats
2 FDA approvalsOriginally approved for its first indication in 2021 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Feb 2021)
- • Approved indication (Sep 2023)
ETHINYL ESTRADIOL AND NORELGESTROMIN Boxed Warning
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Iclevia, are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) and Warnings and Precautions (5.1) ]. WARNING: CIGARETTE SMOKING AND SERIOUS C...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Iclevia, are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) and Warnings and Precautions (5.1) ]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Iclevia is contraindicated in women over 35 years old who smoke. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 5.1 )
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07340190 | CDAK539A12102 2025-521000-22-00 | Ph 1 | not yet recruiting | A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies |
| NCT06039826 | 18533 J1I-MC-GZBV | Ph 1 | completed | A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese |
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.
ETHINYL ESTRADIOL AND NORELGESTROMIN FDA Label Details
Indications & Usage
Iclevia TM (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Iclevia is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For th...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.