DASETTA 1/35 (ethinyl estradiol)
DASETTA 1/35 Tablets are indicated for the prevention of pregnancy in women who elect to use this product 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, the IUD, and the NORPLANT System depends upon the reliability with which they are used.
Details
- Status
- Prescription
- First Approved
- 2011-12-22
- Routes
- ORAL-28
- Dosage Forms
- TABLET
DASETTA 1/35 Approval History
What DASETTA 1/35 Treats
1 FDA approvalsOriginally approved for its first indication in 2011 .
- Other (1)
Other
(1 approval)- • Approved indication (Dec 2011)
DASETTA 1/35 Boxed Warning
WARING: 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 DASETTA TM 1/35, should not be used by women who are over 35 years of age and smoke....
WARING: 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 DASETTA TM 1/35, should not be used by women who are over 35 years of age and smoke.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07340190 | CDAK539A12102 2025-521000-22-00 | Ph 1 | not yet recruiting | A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies |
| NCT06039826 | 18533 J1I-MC-GZBV | Ph 1 | completed | A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese |
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.
DASETTA 1/35 FDA Label Details
Indications & Usage
DASETTA ™ 1/35 Tablets are indicated for the prevention of pregnancy in women who elect to use this product 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, the IUD, and the NORPLANT ® System depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Adapted from Hatcher et al, 1998, Ref. #1. Emergency Con...
WARING: 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, comb...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.