CYTOSOL LABORATORIES RECEIVES FDA APPROVAL TO MARKET TRICITRASOL® ANTICOAGULANT SODIUM CITRATE CONCENTRATE
Cytosol Laboratories, Inc. announces it has received U.S. Food and Drug Administration (FDA) approval for TRICITRASOL® Anticoagulant Sodium Citrate Concentrate, 46.7% Sodium Citrate, for use in granulocytapheresis. TRICITRASOL is the critical, citrate-based anticoagulant used in the collection of granulocytes from normal, blood donors. The harvested granulocytes are used in the treatment of cancer patients.
FOR IMMEDIATE RELEASE
BRAINTREE, MA (PRWEB) July 15, 2003 -- Cytosol Laboratories, Inc. announces it has received U.S. Food and Drug Administration (FDA) approval for TRICITRASOL® Anticoagulant Sodium Citrate Concentrate, 46.7% Sodium Citrate, for use in granulocytapheresis.
TRICITRASOL is the critical, citrate-based anticoagulant used in the collection of granulocytes from normal, blood donors. The harvested granulocytes are used in the treatment of cancer patients.
Since TRICITRASOL was voluntarily recalled in April 2000 for not having appropriate FDA approval, the product has been available for use in granulocytapheresis procedures on a written prescription basis only. The FDA approval of Cytosol Laboratories NDA eliminates the need for a doctor to use the triCitrasol Medical Necessity Qualification Form" to procure the product.
TRICITRASOL contains the highest concentration of citrate ion of any product that has received FDA approval. TRICITRASOL prevents the coagulation of blood by virtue of the citrate ions ability to chelate ionized calcium present in blood to form a non-ionized calcium-citrate complex. When the total dose of citrate ions is greater than the total amount of ionized calcium, blood clotting is prevented.
TRICITRASOL is marketed and distributed exclusively by Citra Anticoagulants, Inc., a wholly-owned subsidiary of Cytosol Laboratories, Inc.
About Cytosol Laboratories
Headquartered in Braintree, Mass., Cytosol Laboratories, Inc., a privately held company, develops and manufactures sterile, medical solutions for third parties. Cytosol has two wholly-owned subsidiaries, Citra Anticoagulants, Inc. and enCyte Systems, Inc. Citra Anticoagulants markets and distributes citrate-based anticoagulants to the medical community. EnCyte Systems markets and distributes medical products that bio-chemically modify red blood cells and medical products that preserve blood cells.
Contact:
Citra Anticoagulants, Inc.
Ronald H. Lewis, Ph.D., President
rlewis@t3cc.com
781-848-2174
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