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

PDP-716 is a novel, once daily, ophthalmic suspension of brimonidine tartrate 0.35%. PDP-716 was developed using SPARC ’s proprietary TearAct technology.

The PDP-716 Complete Response resubmission addresses the FDA CRL issued in July 2023, stating unresolved facility inspection-related conditions at a third-party Active Pharmaceutical Ingredient (API) manufacturing facility. The FDA did not raise any concerns related to the efficacy or safety of PDP-716. SPARC will provide an update after the FDA has determined that the response resubmission is

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