Upcoming FDA decision · October 17, 2026
MR-141 (phentolamine ophthalmic solution 0.75%) PDUFA date: FDA decision expected October 17, 2026
1 day to goMYLAN (VTRS) →
The FDA is expected to decide on MR-141 (phentolamine ophthalmic solution 0.75%) from MYLAN in Presbyopia by the PDUFA target action date of October 17, 2026. For Presbyopia. sNDA. Verified against the company announcement on 2026-10-16.
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: newsroom.viatris.com · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
October 17
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 MR-141 (phentolamine ophthalmic solution 0.75%)?
- The FDA's PDUFA target action date for MR-141 (phentolamine ophthalmic solution 0.75%) is October 17, 2026. The FDA can act before that date, and the review can be extended.
- What is MR-141 (phentolamine ophthalmic solution 0.75%) being reviewed for?
- The application under FDA review covers Presbyopia.
- Which company is developing MR-141 (phentolamine ophthalmic solution 0.75%)?
- 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).