Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
MR-100A-01 is a Viatris Inc. program in contraception. The FDA approved it on Jul 28, 2026. 1 FDA decision on record below. Every date links its source.
FDA approval tracked on pdufa.bio: contraception (approved Jul 28, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Viatris Inc. (VTRS). Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is MR-100A-01's next FDA decision or readout?
No upcoming catalyst is on our calendar for MR-100A-01; 1 FDA decision is on record below.
What happened at MR-100A-01's most recent FDA decision?
On Jul 29, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
What is MR-100A-01 used for?
In our records MR-100A-01 is FDA-approved for contraception (approved Jul 28, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Who makes MR-100A-01?
Viatris Inc. (VTRS).
Has MR-100A-01 been approved by the FDA?
Yes. The FDA approved an application for MR-100A-01 on Jul 29, 2026; the decision page linked above carries the source.
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.
Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.