CAMILA (norethindrone) · Dr. Reddy's
Camila is a progestin-only oral contraceptive (POP) indicated for the prevention of pregnancy. It provides a hormonal contraceptive option for patients who may prefer or require an estrogen-free regimen. To maintain maximum efficacy, the medication must be taken at the same time every day, as the failure rate increases from 0.5% to approximately 5% with typical use (late or omitted pills).
How CAMILA Works
Camila prevents conception through several mechanisms: it thickens cervical mucus to inhibit sperm penetration, suppresses ovulation in approximately half of users, and slows the transport of the ovum through the fallopian tubes. Additionally, it alters the endometrium to inhibit implantation and lowers mid-cycle LH and FSH peaks.
Details
- Status
- Prescription
- First Approved
- 2002-10-21
- Routes
- ORAL-28
- Dosage Forms
- TABLET
CAMILA Approval History
What CAMILA Treats
1 indicationsCAMILA is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
CAMILA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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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.
CAMILA 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 of th...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.