SCHAUMBURG, Ill.—The U.S. Food and Drug Administration has cleared APP Pharmaceuticals to market its 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.
APP is a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc.
“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,” APP said in a news release.
APP said their product is 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, according to APP.
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.”
Heparin Lock Flush Solution, USP is intended to maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling. Heparin Lock Flush Solution may also be used following initial placement of the device in the vein, after each injection of a medication or after withdrawal of blood for laboratory analysis.
