MEDROXYPROGESTERONE ACETATE · Teva
MEDROXYPROGESTERONE ACETATE is FDA-approved to treat 3 conditions (same as PROVERA).
Details
- Status
- Prescription
- First Approved
- 1959-06-18
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
Companies
MEDROXYPROGESTERONE ACETATE Approval History
What MEDROXYPROGESTERONE ACETATE Treats
3 indicationsMEDROXYPROGESTERONE ACETATE is approved for 3 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Secondary Amenorrhea
- Abnormal Uterine Bleeding
- Endometrial Hyperplasia
Same approved indications as PROVERA (same active ingredient).
Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06904274 SUNFLOWER | 22923 | Ph 3 | terminated | Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months |
| NCT05255653 RAINBO | RAINBO ENGOT-en14-1,2,3,4, CCTG EN.10 TAPER arm A POLE | Ph 2, Ph 3 | recruiting | Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features |
| NCT02228681 results posted | GOG-3007 CRAD001CUS236T | Ph 2 | completed | Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer |
| NCT03675139 | 53201014 | Ph 3 | completed | MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia |
| NCT02872818 | 14/128 | Ph 4 | completed | Apoptotic Signaling Pathways in Rats With Endometrial Hyperplasia |
| NCT02340013 | 2014-01 | Ph 4 | completed | Endometrial Shedding Prior to Ovulation Induction Pilot Study |
| NCT01148420 results posted | 13530-01 | Ph 4 | completed | DMPA & High Dose Oral Progestin (MPA) Tablets in Outpatient Treatment of Acute Excessive Vaginal Bleeding |
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.
MEDROXYPROGESTERONE ACETATE FDA Label Details
Indications & Usage
MEDROXYPROGESTERONE ACETATE is FDA-approved to treat 3 conditions — same approved indications as PROVERA.
Looking for the branded version?
DEPO-SUBQ PROVERA 104
Full clinical data, patents, trials, and competitive landscape for medroxyprogesterone acetate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.