ASHLYNA (ethinyl estradiol)
Ashlyna is a combination hormonal medication used by females of reproductive potential to prevent pregnancy. It contains two active components: a progestin called levonorgestrel and an estrogen called ethinyl estradiol. This medication is prescribed for patients who require a reliable method of birth control.
How ASHLYNA Works
This medication works by suppressing ovulation, which is the primary way it prevents pregnancy. By providing a combination of hormones, the drug prevents the release of an egg during the reproductive cycle.
Details
- Status
- Prescription
- First Approved
- 2015-02-23
- Routes
- ORAL
- Dosage Forms
- TABLET
ASHLYNA Approval History
What ASHLYNA Treats
1 indicationsASHLYNA is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pregnancy prevention
ASHLYNA Boxed Warning
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS 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. For this reason, COCs, including Ashlyna, are contraindicated in women who are over 35 years of age and smoke. [See Contraindications ( 4 ), and Warnings and Precautions ( 5.1 )]. WARNING: CIGARETTE SMOKING AND SER...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS 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. For this reason, COCs, including Ashlyna, are contraindicated in women who are over 35 years of age and smoke. [See Contraindications ( 4 ), and Warnings and Precautions ( 5.1 )]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning • Ashlyna is contraindicated in women over 35 years old who smoke. • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.
ASHLYNA 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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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.
ASHLYNA FDA Label Details
Indications & Usage
ASHLYNA 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 contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For t...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.