Posted by Michael Wonder on 14 Jul 2023
FDA issues complete response letter for PDP-716 NDA due to inspection findings at third-party API manufacturing facility
13 July 2023 - No issues with clinical efficacy or safety were identified in the complete response letter.
Sun Pharma Advanced Research Company today announced that the US FDA issued a complete response letter for the new drug application for PDP-716 for the treatment of patients with glaucoma, due to inspection findings at a third-party active pharmaceutical ingredient manufacturing facility.
