Fresenius' Voluven Approved in U.S.

The FDA has approved Voluven, an IV solution that prevents and treats a dangerous loss of blood volume, a condition that sometimes occurs during and after surgery.

In clinical trials, Voluven was compared with other approved blood volume expanders. During orthopedic surgery, Voluven was as safe and effective in expanding blood volume as Hespan, an approved starch solution, the FDA said.

In newborns and infants undergoing major surgery, Voluven was as safe and effective as an equivalent volume of another expander containing albumin. The drug also was found to be as safe as blood volume expanders found overseas in patients ranging in age from younger than 2 to 75.