TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ARANELLE

ETHINYL ESTRADIOL
Approved 2004-09-29
1
Indication
--
Phase 3 Trials
21
Years on Market

Details

Status
Prescription
First Approved
2004-09-29
Routes
ORAL-28
Dosage Forms
TABLET

Companies

Active Ingredient: ETHINYL ESTRADIOL , NORETHINDRONE

ARANELLE Approval History

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What ARANELLE Treats

1 FDA approvals

Originally approved for its first indication in 2004 .

  • Other (1)

ARANELLE Boxed Warning

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke....

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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.

ARANELLE FDA Label Details

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Indications & Usage

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptive products which contain 50 mcg of estrogen, should not be used unless medically indicated. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. 1 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 lowe...

โš ๏ธ BOXED WARNING

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised...

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.