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VTRS PDUFA Date: MR-100A-01(Low dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol))

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ Approved · the FDA decided this application on July 28, 2026 (FDA record; announced July 29, 2026), 2 days before its July 30, 2026 goal date. Decision page with the source and measured reaction.
FDA decision Approved July 28, 2026 · Viatris Inc. · Contraception
More Infectious Disease FDA decisions →All July 2026 PDUFA dates →

The story

MR-100A-01(Low dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol)) was approved by the FDA on July 28, 2026 to treat contraception (a low-dose estrogen birth-control product).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthVERA . 2026-07-07Same month decision . AtaciceptCELC . 2026-07-17Same month decision . Gedatolisib with FulvestrantMNKD . 2026-07-26Same month decision . FUROSCIX ReadyFlow Autoinjector (SCP-1
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

VTRS run-up into the PDUFA (last ~120 days)

$17.39$12.96
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA decisionApproved July 28, 2026
FDA goal date2026-07-30
Drug / candidateMR-100A-01(Low dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol))
IndicationContraception
CompanyViatris Inc.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT05139121 · completed

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See the full 2026 PDUFA calendar →

FAQ

What did the FDA decide on VTRS's MR-100A-01(Low dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol))?
The FDA decided VTRS's (Viatris Inc.) application for MR-100A-01(Low dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol)) on July 29, 2026: Approved. The FDA goal date for this application was 2026-07-30. Verify against the linked primary source.
What is VTRS's drug MR-100A-01(Low dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol))?
MR-100A-01(Low dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol)) is Viatris Inc.'s drug, approved by the FDA on July 28, 2026 for Contraception.
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · large-cap cohortn=790 · median +0.0% · 50% up
under -30%: 2 of 790 (0%)<-30-30 to -15%: 2 of 790 (0%)-15 to -7%: 6 of 790 (1%)-7 to -3%: 29 of 790 (4%)-3 to +3%: 707 of 790 (89%)±3+3 to +7%: 35 of 790 (4%)+7 to +15%: 5 of 790 (1%)+15 to +30%: 2 of 790 (0%)over +30%: 2 of 790 (0%)>+30
Distribution of next-day % moves after the FDA decision for large-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.