Swedish Orphan Biovitrum AB Receives FDA Approval to Manufacture Substance for Kineret with Partner Boehringer Ingelheim


Tuesday, 11 Jun 2013 02:01am EDT 

Swedish Orphan Biovitrum AB announced that it received an 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 United States, and comes as the result of a Supplemental Biologics License Application (sBLA) filed with the FDA in February 2013.