MR-100A-01(Low dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol)) was approved by the FDA on July 28, 2026 for contraception.
Gwyn Lo (norelgestromin and ethinyl estradiol transdermal system), Viatris' internal candidate MR-100A-01, approved as a new low-dose estrogen combined hormonal contraceptive (CHC) patch worn once weekly (Jul 29 2026). The FDA acted one day ahead of the July 30 2026 PDUFA target date. Approval was granted under the 505(b)(2) pathway and supported by the Phase 3 Luminous Study (NCT05139121); the label reflects demonstrated efficacy for women of childbearing potential with a BMI below 30 kg/m².
Gray = run-up into the FDA decision; gold dot & dashed line = the decision day (Jul 29 2026); colored line = the day-of reaction and after. Day-of move: -0% (decision-day close vs prior close). Daily closes via Polygon. Not a prediction.
Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: Viatris: "Viatris Receives U.S. FDA Approval for Gwyn Lo, a Once-Weekly Contraceptive Patch" (Jul 29 2026).
FDA record of the action: the FDA approved on July 28, 2026, per NDA 219990 ORIG-1 (FDA letter). The sponsor announced it on July 29, 2026. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Yes. The FDA approved the application for Gwyn Lo (norelgestromin/ethinyl estradiol) on July 28, 2026, per the FDA's own record. The company announced it on July 29, 2026. The primary source is linked on this page.
Gwyn Lo (norelgestromin/ethinyl estradiol) is a Viatris Inc. (Nasdaq: VTRS) (VTRS) program. The FDA decision came on July 28, 2026; the FDA's own record of the decision is linked on this page.