Home » FDA Accepts Eyenovia’s Resubmitted NDA for Ophthalmic Spray
FDA Accepts Eyenovia’s Resubmitted NDA for Ophthalmic Spray
The FDA has accepted Eyenovia’s resubmitted New Drug Application (NDA) for its MydCombi ophthalmic spray, a drug-device combination product for in-office pupil dilation which uses the company’s investigational Optejet drug delivery technology.
The FDA sent the company a Complete Response Letter in October 2021 which denied approval for the original NDA and reclassified Mydcombi as a drug-device combination product.
The agency’s target action date for the resubmitted NDA is May 8, 2023.
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