FEMLYV
FEMLYV is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ] . Limitations of Use The efficacy of FEMLYV in females with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. FEMLYV is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy ( 1 ) Limitations of Use The efficacy in females of reproductive potential with...
Details
- Status
- Prescription
- First Approved
- 2024-07-22
- Routes
- ORAL
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING
FEMLYV Approval History
What FEMLYV Treats
1 FDA approvalsOriginally approved for its first indication in 2024 .
- Other (1)
FEMLYV Boxed Warning
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptive (COC) use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including FEMLYV, are contraindicated in females who are over 35 years of age and smoke [see Contraindications (4) and Warnings & Precautions (5) ]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDI...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptive (COC) use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including FEMLYV, are contraindicated in females who are over 35 years of age and smoke [see Contraindications (4) and Warnings & Precautions (5) ]. 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 FEMLYV ( 4 ) • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use ( 4 )
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.
FEMLYV FDA Label Details
ProIndications & Usage
FDA Label (PDF)FEMLYV is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ] . Limitations of Use The efficacy of FEMLYV in females with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. FEMLYV is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy Limitations of Use The efficacy in females of reproductive potential with a body mass index of more than 35 kg/m 2 has not been evaluated
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptive (COC) use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For thi...
FEMLYV Patents & Exclusivity
Patents (1 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.