VIENVA (ethinyl estradiol) · XIROMED
Vienva (levonorgestrel and ethinyl estradiol tablets, USP) is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use : The efficacy of levonorgestrel and ethinyl estradiol in women with a body mass index (BMI) of > 35 kg/m 2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported.
Details
- Status
- Prescription
- First Approved
- 2015-05-21
- Routes
- ORAL-28
- Dosage Forms
- TABLET
VIENVA Approval History
What VIENVA Treats
1 FDA approvalsOriginally approved for its first indication in 2015 .
- Other (1)
Other
(1 approval)- • Approved indication (May 2015)
VIENVA Boxed Warning
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptives (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, are contraindicated in women who are over 35 years of age and smoke....
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptives (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, are contraindicated in women who are over 35 years of age and smoke.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07340190 | CDAK539A12102 2025-521000-22-00, 2025 | Ph 1 | 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 |
| NCT07339722 | 27789 J6V-MC-OIAB | Ph 1 | recruiting | A Study of LY4515100 in Healthy Participants |
| 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.
VIENVA FDA Label Details
Indications & Usage
Vienva (levonorgestrel and ethinyl estradiol tablets, USP) is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use : The efficacy of levonorgestrel and ethinyl estradiol in women with a body mass index (BMI) of > 35 kg/m 2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or mo...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.