INCASSIA (norethindrone)
1. Indications Progestin - only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin - only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.
Details
- Status
- Prescription
- First Approved
- 2016-09-23
- Routes
- ORAL-28
- Dosage Forms
- TABLET
INCASSIA Approval History
What INCASSIA Treats
1 FDA approvalsOriginally approved for its first indication in 2016 .
- Other (1)
Other
(1 approval)- • Approved indication (Sep 2016)
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03106454 | HS-09-00669 | Ph 3 | completed | Ovulation Incidence in Oral Contraceptive Users |
| NCT02652650 | CR108093 63623872FLZ1009, 2015-000639-34 | Ph 1 | completed | A Study to Investigate the Effect of JNJ-63623872 at Steady-state on the Steady-state Pharmacokinetics of Ethinylestradiol and Norethindrone |
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.
INCASSIA FDA Label Details
Indications & Usage
1. Indications Progestin - only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin - only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. Table 2: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End o...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.