Gwyn Lo (norelgestromin and ethinyl estradiol transdermal system)

July 29, 2026: Viatris Inc. (NASDAQ: VTRS) announced U.S. FDA approval of Gwyn Lo (norelgestromin and ethinyl estradiol transdermal system), a once-weekly low-dose estrogen combined hormonal contraceptive patch indicated for prevention of pregnancy in women with BMI <30 kg/m² who are appropriate candidates for combined hormonal contraception.

The approval was granted via the FDA 505(b)(2) pathway and supported by the Phase 3 Luminous Study (NCT05139121) and four Phase 1 studies. In the Phase 3 trial, the primary efficacy endpoint Pearl Index in women aged 18–35 was 4.14 (95% CI: 2.77–5.95). Patch adhesion was reported as robust, with 1.3% of 39,790 patches fully detaching over the year-long trial. Common adverse reactions (≥2%) included application-site irritation (4.8%), erythema (3.7%), pruritus (3.7%), intercycle bleeding (3.9%), heavy withdrawal bleeding (2.0%), and nausea (2.0%). Unscheduled bleeding/spotting decreased from 34.5% (mean 3.2 days) in Cycle 1 to 20.0% (2.4 days) by Cycle 13.

Viatris expects Gwyn Lo to be commercially available later in 2026 and plans to provide more detail on its upcoming financial results call.