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VTRS FDA decision — Jul 29, 2026

✓ APPROVED

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

ClassCombined hormonal contraceptive — low-dose estrogen transdermal patch

IndicationPrevention of pregnancy in women with BMI < 30 kg/m² for whom a CHC is appropriate

CompanyViatris Inc. (Nasdaq: VTRS)

Review path505(b)(2); Phase 3 Luminous Study (NCT05139121)

Market-cap tierLarge

Cohort decision-day move (history)±1% median

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).

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