Sun Pharma Resubmits PDP-716 NDA Response to US FDA
Filing Summary
Sun Pharma Advanced Research Company Ltd. (SPARC) has resubmitted a Complete Response Letter (CRL) for the PDP-716 New Drug Application (NDA) to the US Food and Drug Administration (FDA). The resubmission addresses facility inspection-related conditions at a third-party Active Pharmaceutical Ingredient (API) manufacturing site, as noted in the FDA’s CRL from July 2023. No concerns were raised regarding the efficacy or safety of PDP-716. SPARC will update once the FDA reviews the resubmission. PDP-716 is an ophthalmic suspension developed using SPARC’s proprietary TearActTM technology.
Sun Pharma Advanced Research Company Ltd. (SPARC) has announced the resubmission of a Complete Response Letter (CRL) for the PDP-716 New Drug Application (NDA) to the US Food and Drug Administration (FDA). The resubmission was made by Ocuvex Therapeutics Inc. (Ocuvex) and addresses the issues highlighted in the FDA’s CRL issued in July 2023.
The CRL from the FDA identified unresolved facility inspection-related conditions at a third-party Active Pharmaceutical Ingredient (API) manufacturing facility. The FDA did not express any concerns regarding the efficacy or safety of PDP-716 in the CRL. SPARC has stated that it will provide an update once the FDA has determined that the response resubmission is complete.
PDP-716 is a novel, once-daily ophthalmic suspension of brimonidine tartrate 0.35%. It was developed using SPARC’s proprietary TearActTM technology. The technology is designed to enhance the delivery and efficacy of ophthalmic treatments.
Sun Pharma Advanced Research Company Ltd. is a clinical-stage biopharmaceutical company focused on improving standards of care for patients globally through innovation in therapeutics and delivery. The company is committed to advancing the availability of treatment options for patients worldwide.