DESOGESTREL AND ETHINYL ESTRADIOL (desogestrel) · NAARI PTE
Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used.
Details
- Status
- Prescription
- First Approved
- 1999-08-12
- Routes
- ORAL-28, ORAL-21
- Dosage Forms
- TABLET
Companies
DESOGESTREL AND ETHINYL ESTRADIOL Approval History
What DESOGESTREL AND ETHINYL ESTRADIOL Treats
11 FDA approvalsOriginally approved for its first indication in 1999 . Covers 11 distinct patient populations.
- Other (11)
Other
(11 approvals)- • Approved indication (Aug 1999)Label Letter
- • Approved indication (Jul 2005)
- • Approved indication (Jan 2006)
- • Approved indication (Dec 2008)
- • Approved indication (Jul 2013)
- • Approved indication (Aug 2013)
- • Approved indication (May 2015)
- • Approved indication (Jun 2017)
- • Approved indication (Sep 2018)
- • Approved indication (Mar 2026) NewLetter
- • Approved indication (Jul 2026) New
DESOGESTREL AND ETHINYL ESTRADIOL Boxed Warning
CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including desogestrel and ethinyl estradiol tablets, should not be used by women who are over 35 years of age and smoke....
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including desogestrel and ethinyl estradiol tablets, should not be used by women who are over 35 years of age and smoke.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01500473 results posted | CCI-11-00057 | Ph 2 | terminated | Therapeutic Effect of Desogestrel on Ventilatory Control in Patients With Congenital Central Hypoventilation Syndrome |
| NCT01738724 | FMRPUSP-UROGIN-002 | Ph 4 | terminated | Study of the Efficacy of Dienogest in the Treatment of Uterine Leiomyomas When Compared to Desogestrel and Goserelin |
| NCT01243697 RESPIRONDINE | P101001 | Ph 2, Ph 3 | completed | Assessment of Desogestrel in Ondine Syndrome |
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.
DESOGESTREL AND ETHINYL ESTRADIOL FDA Label Details
Indications & Usage
FDA Label (PDF)Desogestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with...
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, com...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.