Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension) for the treatment of macular edema associated with uveitis.
Clearside’s resubmission is a full and complete response to all of the items identified in the Complete Response Letter (CRL) received from the FDA on October 18, 2019. Clearside believes this application will be considered a Class 2 resubmission, with a targeted six-month review timeline under the Prescription Drug User Fee Act.
https://finance.yahoo.com/news/clearside-biomedical-announces-resubmission-drug-110500856.html
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