Contraception
VTRSViatris IncCatalyst overview
Research summary
This catalyst tracks a Approved update for Low Dose Estrogen Weekly Patch (Transdermal Contraceptive) in Contraception. The expected timing is based on the latest available company guidance and may change.
12/18/25:- FDA accepted NDA for low dose weekly patch. PDUFA decision expected July 30, 2026. 02/26/26:- NDA acceptance and July 30, 2026 PDUFA date highlighted in company financial update. 05/01/26:- ACOG May 2026 posters share Ph3 NCT05139121 efficacy/safety, adhesion, PK, cycle-control data. PDUFA July 30, 2026. 05/07/26:- Q1 2026 update reiterates positive Ph3 ACOG 2026 data; PDUFA decision remains July 30, 2026. 07/29/26:- FDA approved Gwyn Lo low-dose CHC patch for contraception; Luminous Study (NCT05139121) supported approval. 08/06/26:- Gwyn Lo approval reiterated; commercial availability expected later in 2026.
Verification
Confirm timing and program details against the company announcement or filing.