ETHINYL ESTRADIOL; ETONOGESTREL (ethinyl estradiol) · Teva
A flexible vaginal ring (branded as NuvaRing) used for birth control. One ring is worn continuously for three weeks, then removed for a one-week break before starting a new ring. Not recommended for smokers over 35 or individuals at elevated risk for blood clots.
How ETHINYL ESTRADIOL; ETONOGESTREL Works
As a combination hormonal contraceptive, the ring releases etonogestrel and ethinyl estradiol that are absorbed vaginally to suppress ovulation and prevent pregnancy.
Details
- Status
- Prescription
- First Approved
- 2021-01-13
- Routes
- VAGINAL
- Dosage Forms
- RING
ETHINYL ESTRADIOL; ETONOGESTREL Approval History
What ETHINYL ESTRADIOL; ETONOGESTREL Treats
1 indicationsETHINYL ESTRADIOL; ETONOGESTREL is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pregnancy prevention
ETHINYL ESTRADIOL; ETONOGESTREL Boxed Warning
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including etonogestrel and ethinyl estradiol vaginal ring, should not be used by women who are over 35 years of age and smoke [see Contraindications ( 4 )]. WARNING: CIGARETTE SMOKING AND ...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including etonogestrel and ethinyl estradiol vaginal ring, should not be used by women who are over 35 years of age and smoke [see Contraindications ( 4 )]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Women over 35 years old who smoke should not use etonogestrel and ethinyl estradiol vaginal ring. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. ( 4 )
ETHINYL ESTRADIOL; ETONOGESTREL 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.
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Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
ETHINYL ESTRADIOL; ETONOGESTREL FDA Label Details
Indications & Usage
FOR VAGINAL USE ONLY Etonogestrel and ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy. Etonogestrel and ethinyl estradiol vaginal ring is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. Fo...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.