FDA Issues Complete Response Letter for PDP-716 NDA Due to Inspection Findings at Third-Party API Manufacturing Facility

No issues with clinical efficacy or safety were identified in the CRL No additional clinical data or trials have been requested Mumbai, India, July 13, 2023 - Sun Pharma Advanced Research Company Ltd. (Reuters: SPRC.BO, Bloomberg: SPADV IN,...
Source: Drugs.com - New Drug Applications - Category: Drugs & Pharmacology Source Type: news