LO LOESTRIN FE
Details
- Status
- Prescription
- First Approved
- 2010-10-21
- Routes
- ORAL
- Dosage Forms
- TABLET
LO LOESTRIN FE Approval History
What LO LOESTRIN FE Treats
1 FDA approvalsOriginally approved for its first indication in 2010 .
- Other (1)
LO LOESTRIN 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 w omen who are over 35 years of age and smoke [ see Contraindications (4) ] . WARNING : CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See Full Prescribing Inform...
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 w omen 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. Women over 35 years old who smoke should not use Lo Loestrin Fe ( 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.
LO LOESTRIN FE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Lo Loestrin ® Fe is indicated for use by women to prevent pregnancy [ see Clinical Studies ] . The efficacy of Lo Loestrin Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated. Lo Loestrin 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 Lo Loestrin Fe in women with a body mass index of > 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 . Fo...
LO LOESTRIN FE Patents & Exclusivity
Patents (1 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.