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Swedish Orphan Biovitrum AB (publ) (Sobi) today announced receipt of approval from the Food and Drug Administration (FDA) for the manufacture of drug substance for Kineret® (anakinra) at Boehringer Ingelheim’s microbial site in Vienna, Austria. The approval allows for distribution of Kineret in the US, and comes as the result of a Supplemental Biologics License Application (sBLA) filed with the FDA in February 2013.
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