LEVONORGESTREL AND ETHINYL ESTRADIOL (ethinyl estradiol)
Levonorgestrel and ethinyl estradiol tablets, 0.15 mg/30 mcg are indicated for use by females of reproductive potential to prevent pregnancy.
Details
- Status
- Prescription
- First Approved
- 2003-04-29
- Routes
- ORAL, ORAL-28, ORAL-21
- Dosage Forms
- TABLET
Companies
LEVONORGESTREL AND ETHINYL ESTRADIOL Approval History
What LEVONORGESTREL AND ETHINYL ESTRADIOL Treats
20 FDA approvalsOriginally approved for its first indication in 2003 . Covers 20 distinct patient populations.
- Other (20)
Other
(20 approvals)- • Approved indication (Apr 2003)
- • Approved indication (Nov 2004)
- • Approved indication (May 2006)Label
- • Approved indication (Jun 2011)
- • Approved indication (Oct 2012)
- • Approved indication (Dec 2012)
- • Approved indication (Jan 2013)
- • Approved indication (Oct 2013)
- • Approved indication (Feb 2014)
- • Approved indication (Dec 2014)
- • Approved indication (Apr 2015)
- • Approved indication (Apr 2015)
- • Approved indication (Jun 2015)
- • Approved indication (Nov 2015)
- • Approved indication (Nov 2015)
- • Approved indication (Dec 2015)
- • Approved indication (Mar 2018)
- • Approved indication (Aug 2020)
- • Approved indication (Oct 2020)
- • Approved indication (Feb 2023)
LEVONORGESTREL AND ETHINYL ESTRADIOL 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 levonorgestrel and ethinyl estradiol tablets, are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS and WARNINGS (1) ]....
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 levonorgestrel and ethinyl estradiol tablets, are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS and WARNINGS (1) ].
Clinical Trial Registry
3 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 |
| NCT02531321 results posted | HS-15-00112 | Ph 4 | terminated | Protease Inhibitors and Combined Oral Contraceptive Pharmacokinetics and Pharmacodynamics |
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.
LEVONORGESTREL AND ETHINYL ESTRADIOL FDA Label Details
Indications & Usage
FDA Label (PDF)Levonorgestrel and ethinyl estradiol tablets, 0.15 mg/30 mcg are 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.