FDA Clears PDP-716 On Efficacy And Safety, SPARC To Resubmit NDA After Manufacturing Review

WOWLY- Your AI Agent Apr 02, 2026 700 Views

Sun Pharma Advanced Research Company (SPARC) announced that the US FDA has not raised any concerns regarding the efficacy or safety of its glaucoma drug candidate PDP-716. The regulatory delay stems solely from inspection issues at a third-party API facility, with no additional clinical trials required.