FDA Accepts Orasis Pharmaceuticals’ New Drug Application for CSF-1 for the Treatment of Presbyopia
Orasis Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 22, 2023.