FDA approves new vial size for Privigen

KING OF PRUSSIA, Pa. — The Food and Drug Administration has approved a new vial size for a drug made by CSL Behring to treat a bleeding disorder and an immune disorder, the company said Thursday.

The company announced the approval of a 40 g vial size for Privigen (immune globulin intravenous [human]), used to treat primary immunodeficiency and chronic immune thrombocytopenic purport. The company said the new vial size would simplify preparation and administration of the drug when high volumes are provided. In addition to the new vial size, scheduled for introduction in June, the drug will be available in 5 g, 10 g and 20 g sizes.

"CSL Behring strives to bring new innovations to the healthcare marketplace and deliver products that enhance the patient experience," CSL Behring SVP research and development Val Romberg said. "The 40-gram vial size for Privigen continues that commitment by reducing the complexity of administration and increasing time savings for healthcare providers."


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