MR-107A-02 PDUFA date: FDA decision expected December 27, 2026
The FDA is expected to decide on MR-107A-02 from MYLAN in moderate-to-severe acute pain by the PDUFA target action date of December 27, 2026. For moderate-to-severe acute pain. Extracted from SEC filing: EX-99.1
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 20, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
Get an email when this FDA date moves or the decision lands
Track MYLAN (VTRS) and we email you when an FDA date moves, 7 days and 1 day before the decision when the exact day is known, and when it is announced. Free account, no card.
Questions about this FDA decision
- When is the PDUFA date for MR-107A-02?
- The FDA's PDUFA target action date for MR-107A-02 is December 27, 2026. The FDA can act before that date, and the review can be extended.
- What is MR-107A-02 being reviewed for?
- The application under FDA review covers moderate-to-severe acute pain.
- Which company is developing MR-107A-02?
- MYLAN (VTRS).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).