FDA Expands fibryga® (IMAGE)

Yankee Public Relations

FDA Expands fibryga®

Caption

The U.S. Food and Drug Administration (FDA) has approved two Octapharma supplements to Biological License Applications, strengthening the company's pediatric critical care product portfolio. The supplement approvals resulted in new product labeling for Octaplas™, Pooled Plasma (Human), Solvent/Detergent (S/D) Treated Solution for Intravenous Infusion, and fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution. The FDA expanded fibryga® indication to include treatment of acute bleeding episodes in pediatric congenital fibrinogen deficiency patients under 12 years of age.

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Octapharma USA

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