Drugs / Transdermal Contraceptive
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | contraception | 2025-12-18 | “FDA has accepted for review the NDA for the Company's investigational low-dose estrogen CHC weekly patch” viatris.com ↗ “FDA accepts NDA for low dose estrogen weekly patch for contraception” viatris.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT02367833 | Jan 2015 → Dec 2017 | bone disorder | Penn State University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-12-18 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Regulatory Viatris Provides Pipeline Update on Four Regulatory Milestones viatris.com ↗
The U.S. FDA has accepted for review the New Drug Application (NDA) for the Company's investigational low dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol) for contraception. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2025-12-18 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Viatris Provides Pipeline Update on Four Regulatory Milestones viatris.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Transdermal Contraceptive | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02367833 ↗ |
| Route | Other | “Participants in the TDC group will apply a 20 cm2 patch (Xulane: 20µg/d EE,150µg/d norelgestromin) to the abdomen, upper arm or buttock.” NCT02367833 ↗ |