- FDA approved Gwyn Lo, Viatris’ once-weekly combined hormonal contraceptive patch, for women of childbearing potential with BMI below 30 kg/m² who are appropriate candidates for combined hormonal contraception.
- Viatris expects Gwyn Lo to become commercially available later in 2026, adding a new women’s-health product to its U.S. portfolio.
- FDA issued Viatris an untitled letter over a direct-to-consumer Tobi Podhaler video that the agency said misleadingly suggested the cystic-fibrosis inhaler can be used anywhere without concern.
- The agency said Tobi Podhaler’s instructions require adequate lighting, stable conditions, dry storage and handling that avoids moisture exposure, because improper use can result in a suboptimal dose.
Quotes
“Gwyn Lo will provide a discreet option for women seeking a reversible, non-invasive, once-weekly contraception patch with a low dose of estrogen”
“set the mouthpiece aside on a clean, dry surface”
Sources
- <a href="https://www.fiercepharma.com/marketing/viatris-runs-fda-roadblocks-after-advertising-go-use-cystic-fibrosis-inhaler" hreflang="en">Viatris runs into FDA roadblock after advertising on-the-go use of cystic fibrosis inhaler</a>FiercePharma
- Viatris Receives U.S. FDA Approval for Gwyn Lo™, a Once-Weekly Contraceptive PatchPR Newswire