LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Details
- Status
- Prescription
- First Approved
- 2011-05-31
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL Approval History
What LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL Treats
7 FDA approvalsOriginally approved for its first indication in 2011 . Covers 7 distinct patient populations.
- Other (7)
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL Boxed Warning
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning . • Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are 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. ( 4 ) Cigarette smoking increases the risk of serious cardiovascu...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning . • Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are 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. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. COCs, including levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets, are contraindicated in women who are over 35 years of age and smoke [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )].
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 AND ETHINYL ESTRADIOL FDA Label Details
ProIndications & Usage
Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for use by females of reproductive age to prevent pregnancy.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning . • Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in women over 35 ye...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.