SILVER SPRING, Md., Dec. 10 The U.S. Food and Drug Administration today approved InterSol, the first solution approved to replace a portion of plasma used when storing platelets for up to five days, allowing some of the donor plasma to be used for other purposes.
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In the United States, platelets, which are blood components that help with blood clotting, have been stored in donor plasma. About 65% of that plasma is replaced with the InterSol platelet additive solution.
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Platelets are used to prevent or treat bleeding in individuals undergoing chemotherapy for cancer, after major trauma, during or after surgery, and in individuals who do not produce platelets. InterSol solution does not have a therapeutic effect by itself but acts to provide nutrients and an appropriate environment in which to store platelets.
"The approval of InterSol is a significant step in the development and marketing of novel processes for the storage of platelets," said Karen Midthun, MD, acting director of FDA's Center for Biologics Evaluation and Research.
The InterSol platelet additive solution is an aqueous solution of various salt components. It replaces a proportion of plasma in the storage of platelets collected by an automated instrument.
InterSol solution is manufactured by Fenwal Inc., Lake Zurich, IL.
Draft: OBRR, 10/19/09Edits: W. J. Gardner, 10/20/09Edits: D. Bartell, 10/20/09Edits: L. McNeill, 10/20/09Revised: D. Bartell, 10/20/09Edits: S. Burgess, 10/26/09Edits: G. Michaud, 10/26/09CBER Clearance: D. Maloney, 10/27/09Edits/Clearance: OPA, 10/30/09Comments: M. Robinson, HHS, 11/27/09Edits: W. Gardner, 11/30/09Edits: H. Salim, 11/30/09Edits and CBER Clearance: B. Yetter, 12/1/09Edits: N. Jain, 12/1/09Review/Clearance: G. Michaud, 12/1/09Media Inquiries: Shelly Burgess, 301-796-4651, [email protected] Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
