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(20/11/2025 15:36)

SPARC announces resubmission of FDA Complete Response Letter for PDP-716 NDA

Sun Pharma Advanced Research Company Ltd (SPARC) announced that Ocuvex Therapeutics Inc. has resubmitted the Complete Response Letter (CRL) for the PDP-716 New Drug Application (NDA) to the US FDA.

The resubmission addresses facility inspection-related issues at a third-party API manufacturing site, which were highlighted in the FDA’s July 2023 CRL. The agency had not raised any concerns regarding PDP-716’s safety or efficacy.

SPARC said it will provide further updates once the FDA confirms the resubmission is complete.
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