TYDEMY (drospirenone)
Tydemy is a combination oral contraceptive (COC) containing drospirenone (a progestin), ethinyl estradiol (an estrogen), and levomefolate calcium (a folate). It is indicated for use by females of reproductive potential to prevent pregnancy. Additionally, it is indicated to raise folate levels in women who choose an oral contraceptive to reduce the risk of neural tube defects in pregnancies conceived while taking the product or shortly after discontinuation.
How TYDEMY Works
Combination oral contraceptives (COCs) prevent pregnancy primarily by suppressing ovulation. The addition of levomefolate calcium does not affect contraceptive efficacy but serves to increase folate stores.
Details
- Status
- Prescription
- First Approved
- 2017-12-12
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
TYDEMY Approval History
What TYDEMY Treats
1 indicationsTYDEMY is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Neural Tube Defect
TYDEMY Boxed Warning
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see Contraindications (4)]. See full prescribing information for complete boxed warning. Women over 35 years old who smoke s...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see Contraindications (4)]. See full prescribing information for complete boxed warning. Women over 35 years old who smoke should not use Tydemy. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 )
Clinical Trial Registry
6 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 |
| NCT06345560 | 077766 | Ph 1, Ph 2 | recruiting | Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study |
| NCT07293728 | STUDY00028768 | Ph 4 | not yet recruiting | A Randomized Feasibility Trial Comparing Drospirenone and Norethindrone for Postpartum Hypertension Management in Preeclampsia |
| NCT05461573 | CF113-303 | Ph 3 | completed | Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females |
| NCT05706753 | CR109284 2022-002828-12, 70033093THR1009 | Ph 1 | completed | A Study of Milvexian in Healthy Adult Females |
| 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.
TYDEMY FDA Label Details
Indications & Usage
TYDEMY is indicated for the treatment of Neural Tube Defect.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For t...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.