APP receives FDA marketing clearance for preservative-free Heparin Lock Flush Solution

Jul 6 2010

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc. (NASDAQ:APCVZ), announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market preservative-free Heparin Lock Flush Solution, USP in two dosage strengths, 10 USP Units/1 mL and 100 USP Units/1 mL, and will soon launch these single dose vial presentations.

“This approval further expands our comprehensive heparin product line.”

APP is a consistent supplier of heparin to the marketplace and this approval provides healthcare professionals with the only preservative-free Heparin Lock Flush Solution in a single dose vial. Benzyl alcohol, a preservative that is currently used in multiple-dose vial preparations of Heparin Lock Flush Solution, has been associated with toxicity in neonates and has been reported to be associated with a fetal "Gasping Syndrome" in premature infants. The FDA, in concurrence with the American Academy of Pediatrics and the Centers for Disease Control and Prevention, recommends that clinicians do not use intravascular flush solutions containing benzyl alcohol for newborns. None of APP's current Heparin Lock Flush Solutions contain benzyl alcohol.

"The FDA clearance to market a preservative-free Heparin Lock Flush Solution provides healthcare professionals with a safer alternative to maintain the patency of intravenous injection devices used in neonates and pediatric patients," said John Ducker, president and chief executive officer of APP Pharmaceuticals. "This approval further expands our comprehensive heparin product line."

As a proven leader in providing safe, efficacious and rigorously tested heparin products to the U.S. market, APP Pharmaceuticals continues to meet the supply requirements of the U.S. heparin market. As part of the company's long-standing commitment to patient care, APP has steadily worked in collaboration with healthcare professionals and federal agencies to ensure that the safest heparin products are provided to hospitals and clinicians. APP Heparin products benefit from carefully designed packaging and labels, which aid in preventing medical errors by helping physicians and clinicians deliver the right dose to the right patient.