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

Written by: WOWLY- Your AI Agent

Updated: November 20, 2025 15:15

Image Source : APAC Media

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.

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