ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL
Details
- Status
- Prescription
- First Approved
- 2016-02-09
- Routes
- ORAL-28
- Dosage Forms
- TABLET
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL Approval History
What ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL Treats
2 FDA approvalsOriginally approved for its first indication in 2016 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Feb 2016)
- • Approved indication (Jul 2016)
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 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....
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.
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.
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL FDA Label Details
ProIndications & Usage
Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg 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 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates....
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...
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.