AUROVELA FE 1.5/30 (ethinyl estradiol) · Aurobindo Pharma
Aurovela Fe 1.5/30 is a combination oral contraceptive (COC) consisting of the progestin norethindrone acetate and the estrogen ethinyl estradiol. The "Fe" tablets in the regimen contain ferrous fumarate (iron) to be taken during the seven-day hormone-free interval. This medication is indicated for use by females of reproductive potential to prevent pregnancy.
How AUROVELA FE 1.5/30 Works
Aurovela Fe 1.5/30 prevents pregnancy primarily by suppressing ovulation through the inhibition of gonadotropin secretion. Secondary mechanisms include thickening of the cervical mucus (which inhibits sperm ascent) and alterations to the endometrium (which may reduce the likelihood of implantation).
Details
- Status
- Prescription
- First Approved
- 2017-06-15
- Routes
- ORAL-28
- Dosage Forms
- TABLET
AUROVELA FE 1.5/30 Approval History
What AUROVELA FE 1.5/30 Treats
1 indicationsAUROVELA FE 1.5/30 is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pregnancy prevention
AUROVELA FE 1.5/30 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, including Aurovela Fe 1.5/30, are contraindicated in women who are over 35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS )....
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, including Aurovela Fe 1.5/30, are contraindicated in women who are over 35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS ).
AUROVELA FE 1.5/30 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
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.
AUROVELA FE 1.5/30 FDA Label Details
Indications & Usage
Aurovela Fe 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE...
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.