LARIN 24 FE (ethinyl estradiol)
Larin 24 Fe is a combination oral contraceptive (COC) indicated for use by women to prevent pregnancy. It contains two active hormonal components: norethindrone acetate (a progestin) and ethinyl estradiol (an estrogen). The efficacy of Larin 24 Fe in women with a body mass index (BMI) greater than 35 kg/m² has not been evaluated.
How LARIN 24 FE Works
Larin 24 Fe prevents pregnancy primarily by suppressing ovulation. Combination hormonal contraceptives also induce secondary changes that contribute to efficacy, including thickening of the cervical mucus (to inhibit sperm penetration) and alterations in the endometrium (to reduce the likelihood of implantation).
Details
- Status
- Prescription
- First Approved
- 2015-02-18
- Routes
- ORAL
- Dosage Forms
- TABLET
LARIN 24 FE Approval History
What LARIN 24 FE Treats
1 FDA approvalsOriginally approved for its first indication in 2015 .
- Other (1)
Other
(1 approval)- • Approved indication (Feb 2015)
LARIN 24 FE Boxed Warning
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See Full Prescribing Information for complete boxed warning. ● LARIN 24 Fe is contraindicated in women over 35 years old who smoke. (4) ● Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. (4) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk ...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See Full Prescribing Information for complete boxed warning. ● LARIN 24 Fe is contraindicated in women over 35 years old who smoke. (4) ● Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. (4) 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) ] .
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.
LARIN 24 FE FDA Label Details
Indications & Usage
LARIN 24 Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by women to prevent pregnancy. The efficacy of LARIN 24 Fe in women with a body mass index (BMI) of >35 kg/m 2 has not been evaluated. Larin 24 Fe is indicated for use by women to prevent pregnancy [see Clinical Studies ] . The efficacy of LARIN 24 Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See Full Prescribing Information for complete boxed warning. ● LARIN 24 Fe is contraindicated in women over 35 years old who smoke. (4) ● Cigarette smoking increases the risk of ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.