Ocuphire Gets PDUFA Date of September 28 for Nyxol® Eye Drops

 If Approved Later This Year, Nyxol Could be the Only Commercially Available Eye Drop for Reversal of Dilation

Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Nyxol® (phentolamine ophthalmic solution 0.75%) for the treatment of pharmacologically-induced mydriasis (RM). The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of September 28, 2023.

https://finance.yahoo.com/news/ocuphire-announces-fda-acceptance-drug-130000621.html