OFFICIAL-CORRECTED-US FDA clears Fresenius drug for blood loss
(Official correction from U.S. FDA noting maker of Hespan is B. Braun Medical, not Abbott Laboratories, in paragraph 4)
WASHINGTON, Dec 27 (Reuters) - U.S. regulators said on Thursday said they approved a treatment for blood loss during and after surgery made by Germany's Fresenius (FREG_p.DE) (FMEG.DE).
The Food and Drug Administration said it cleared the treatment, an intravenous solution called Voluven to prevent and treat a dangerous loss of blood volume during and after surgery.
The treatment is a man-made starch that expands blood plasma volume. The most common side effects were nausea and itching, the FDA said.
In a study, it proved as safe and effective as a drug made by B. Braun Medical Inc, called Hespan, when used during orthopedic surgery, the regulatory agency said. The company, based in Pennsylvania, is a U.S. unit of privately held B. Braun Melsungen, AG.
(Reporting by Kim Dixon; Editing by Leslie Gevirtz)
