TAYTULLA (ethinyl estradiol)
Taytulla is a combination hormonal medication used by women of reproductive age to prevent pregnancy. It contains two active components, a progestin called norethindrone acetate and an estrogen called ethinyl estradiol. This option is prescribed for females of reproductive potential, though its effectiveness has not been established for those with a body mass index greater than 35.
How TAYTULLA Works
This medication works by lowering the overall risk of becoming pregnant. It achieves this therapeutic effect primarily by suppressing ovulation during the menstrual cycle.
Details
- Status
- Prescription
- First Approved
- 2013-04-19
- Routes
- ORAL
- Dosage Forms
- CAPSULE
TAYTULLA Approval History
What TAYTULLA Treats
1 indicationsTAYTULLA is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pregnancy prevention
TAYTULLA 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 should not be used by women who are over 35 years of age and smoke [see Contraindications (4) and Warnings & Precautions (5.1) ] . WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS S...
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 should not be used by women who are over 35 years of age and smoke [see Contraindications (4) and Warnings & Precautions (5.1) ] . 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 TAYTULLA. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 )
TAYTULLA 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.
Drugs Similar to TAYTULLA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
TAYTULLA FDA Label Details
Indications & Usage
FDA Label (PDF)TAYTULLA is indicated for the treatment of Pregnancy prevention.
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.