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.
Run-up & decision-day reaction
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.
Key facts
FDA decision date2026-07-29
PDUFA target date2026-07-30 (acted early)
OutcomeApproved
Brand / candidateGwyn Lo (MR-100A-01)
Active ingredientsNorelgestromin 220 mcg/day + ethinyl estradiol 20 mcg/day
Was Gwyn Lo (norelgestromin/ethinyl estradiol): once-weekly contraceptive approved by the FDA?
Yes. The FDA approved the application for Gwyn Lo (norelgestromin/ethinyl estradiol): once-weekly contraceptive on July 29, 2026. The primary source is linked on this page.
Which company is behind Gwyn Lo (norelgestromin/ethinyl estradiol): once-weekly contraceptive ?
Gwyn Lo (norelgestromin/ethinyl estradiol): once-weekly contraceptive is a Viatris Inc. (Nasdaq: VTRS) (VTRS) program. The FDA decision came on July 29, 2026; the company's own announcement is linked on this page.
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