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Clearside Biomedical Receives Notification of FDA Acceptance of NDA Filing for XIPERE™ (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection with PDUFA Date Set for October 19, 2019
ALPHARETTA, Ga., Feb. 20, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, announced today that it received notification from the U.S. Food and Drug Administration (FDA) that the Agency has accepted for review the New Drug Application (NDA) for XIPERE (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection for the treatment of macular edema associated with uveitis. The FDA has determined that the application is sufficiently complete to permit a substantive review.
Wednesday, February 20, 2019 - 07:05