phentolamine ophthalmic solution 0.75% (MR-141) — Regulatory decision
H2 2026
The supplemental NDA was accepted for review by the FDA in February 2026 and the Company anticipates FDA action during the second half of 2026.Source filing
VIATRIS INC · Data as of 2026-09-08
H2 2026
The supplemental NDA was accepted for review by the FDA in February 2026 and the Company anticipates FDA action during the second half of 2026.Source filing
Oct 17
The FDA has assigned a PDUFA goal date of October 17, 2026.Source filing
Dec 27
The FDA has assigned a PDUFA goal date of December 27, 2026.Source filing