By PPN News Staff
The FDA approved Octapharma supplements to two Biological License Applications, strengthening the company’s pediatric critical care product portfolio.
The agency expanded the indication for fibrinogen (human) lyophilized powder for reconstitution (human fibrinogen concentrate [HFC]; Fibryga) to include treatment of acute bleeding episodes in pediatric congenital fibrinogen deficiency (CFD), also known as factor 1 deficiency, in patients younger than 12 years of age.