Second Octapharma Octagam 10% Manufacturing Site Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved Octapharma’s manufacturing facility in Vienna, Austria, for the production of Octagam 10% (immune globulin intravenous [human] 10% [100 mg/mL] liquid preparation), which became available in the U.S. in October. This approval means that Octagam 10% can now be manufactured

 or the U.S. market at FDA-licensed facilities in both Stockholm and Vienna.

In July, FDA approved Octagam 10% for the treatment of adults with chronic immune thrombocytopenic purpura, a platelet disorder that can result in easy or excessive bruising and bleeding. Octapharma has been marketing Octagam 5% (immune globulin intravenous [human] 5% [50 mg/mL] liquid preparation) to treat primary humoral immunodeficiency since 2004. Octagam 5% is also manufactured at the FDA-licensed manufacturing facilities in Stockholm and Vienna.

“The FDA approval of Octapharma’s Vienna manufacturing site for Octagam 10% is great news for patients, as it will help facilitate product availability and enhances production flexibility,” said Flemming Nielsen, president of Octapharma USA. “Octapharma owns six manufacturing facilities internationally, which all utilize the latest technology and strict quality control processes.”