Dextenza Approval Status
- FDA approved: No
- Brand name: Dextenza
- Generic name: dexamethasone
- Dosage form: Intracanalicular Depot
- Company: Ocular Therapeutix, Inc.
- Treatment for: Postoperative Ocular Inflammation
Dextenza (dexamethasone) is an investigational intracanalicular depot corticosteroid formulation delivering sustained release dexamethasone to the ocular surface for the treatment of post-surgical ocular inflammation and pain.In July 2016, Ocular Therapeutix, Inc. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Dextenza (dexamethasone insert) 0.4 mg, for intracanalicular use. The concerns raised by the FDA pertain to deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the manufacturing facility. The CRL did not identify any efficacy or safety concerns with respect to the clinical data provided in the NDA nor any need for additional clinical trials.
Development Status and FDA Approval Process for Dextenza
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