Upcoming FDA decision · December 27, 2026
ustekinumab PDUFA date: FDA decision expected December 27, 2026
70 days to goMYLAN (VTRS) →
The FDA is expected to decide on ustekinumab 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 18, 2026. Confirm dates against the company's or the FDA's announcement before acting.
December 27
Target action date
NDA
Stage
Verified
Date confidence
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for ustekinumab?
- The FDA's PDUFA target action date for ustekinumab is December 27, 2026. The FDA can act before that date, and the review can be extended.
- What is ustekinumab being reviewed for?
- The application under FDA review covers moderate-to-severe acute pain.
- Which company is developing ustekinumab?
- 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).