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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).
Propoxyphene is an opioid medication that was first approved by FDA in 1957. It has been marketed in the United States since 1976 as a Schedule IV Controlled Substances used as either a single ingredient (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet) to treat mild to moderate pain. Revision of the review of serious adverse events reported in association with propoxyphene and Darvocet (propoxyphene/acetaminophen);NDA #s 10996, 10997, 16827, 16829, 16861, 16862, 16863, 16864, 76429, 17122, 16844, & 17507 (July 25, 2005 memo) (PDF - 475KB).