AUROVELA 24 FE
Details
- Status
- Prescription
- First Approved
- 2017-06-15
- Routes
- ORAL
- Dosage Forms
- TABLET
AUROVELA 24 FE Approval History
What AUROVELA 24 FE Treats
1 FDA approvalsOriginally approved for its first indication in 2017 .
- Other (1)
Other
(1 approval)- • Approved indication (Jun 2017)
AUROVELA 24 FE 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) ] . WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See Full Prescribing Information f...
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) ] . WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See Full Prescribing Information for complete boxed warning. Aurovela 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 )
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 24 FE FDA Label Details
ProIndications & Usage
Aurovela 24 Fe is indicated for use by women to prevent pregnancy [see Clinical Studies ] . The efficacy of Aurovela 24 Fe in women with a body mass index (BMI) of greater than 35 kg/m 2 has not been evaluated. Aurovela 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 Aurovela 24 Fe in women with a body mass index (BMI) of greater 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 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.