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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).
Teva thus obtained FDA's approval of tbo-filgrastim through the standard application process for new drugs and certain biological products. According to the FDA-approved labeling (PDF) for tbo-filgrastim, the drug is a short-acting recombinant G-CSF product.