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DUBLIN, June 15, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN) announced today that the 510(k) Premarket Notification Application for the XEN Glaucoma Treatment System (consisting of the XEN45 Gel Stent and the XEN Injector) has been accepted for filing by the U.S. Food and Drug Administration (FDA).
Omeros expects to launch the drug in the United States in late summer/early fall 2014. Send comments and news tips to news@medscape.net. Cite this article: FDA Approves Omidria for Cataract Surgery, Lens Replacement. The US Food and Drug Administration (FDA) has approved phenylephrine and ketorolac injection (Omidria, Omeros Corporation) 1%/3% for use during cataract surgery or intraocular lens replacement (ILR), according to a company statement.