U.S. FDA Approves Terumo BCT’s Sodium Citrate 4% w/v Anticoagulant Solution Amid Shortage
July 18 2018 - 10:04AM
The U.S. Food and Drug Administration (FDA) recently approved
Terumo BCT’s Sodium Citrate 4% w/v Anticoagulant Solution USP,
indicated for anticoagulating whole blood during automated
apheresis procedures. On an official FDA shortage list for over a
year, sodium citrate anticoagulant solution is commonly used during
apheresis procedures that collect plasma that is later used to
treat serious medical conditions. Terumo BCT is a global
leader in blood component, therapeutic apheresis and cellular
technologies with nearly 7,000 employees and manufacturing
facilities in Belgium, India, Japan, the U.K., the U.S. and
Vietnam. The company has 30 years of experience making
pharmaceutical solutions. The newly approved sodium citrate will be
available in the U.S. later this summer.“We heard from numerous
customers that the shortage of sodium citrate was starting to have
an impact on patients,” said Tim Costello, a vice president of
Terumo BCT. “This FDA approval will help alleviate the U.S.
shortage and improve patient lives.”Terumo BCT’s manufacturing
facility in Larne, U.K., specializes in liquid solutions including
Sodium Citrate 4% w/v Anticoagulant Solution USP. The company has
supplied parts of Europe, Asia and Australia with this same sodium
citrate product for more than 10 years.Sodium citrate is used by
blood centers and plasma collection organizations. The solution is
also used in plasma fractionation, a process that enables the
derivatives to be used in pharmaceuticals.
About Terumo
BCTTerumo BCT, a global leader in blood component, therapeutic
apheresis and cellular technologies, is the only company with the
unique combination of apheresis collections, manual and automated
whole blood processing and pathogen reduction technologies. We
believe in the potential of blood to do even more for patients than
it does today. This belief inspires our innovation and strengthens
our collaboration with customers.
Bradley Hein
Terumo BCT
+1.303.542.5396
press@terumobct.ocm