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SCHAUMBURG, Ill., Jan. 9, 2013 (GLOBE NEWSWIRE) -- Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT) today announced that due to the current critical shortage of Sodium Bicarbonate Injection, USP in the United States market, Sagent, in cooperation with the U.S. Food and Drug Administration ("FDA"), has initiated the temporary importation into the U.S. of a non-FDA approved 8.4% Sodium Bicarbonate Injection (1 mEQ/mL) from Phebra Pty Ltd., an Australian manufacturer. Please refer to the
Dear Healthcare Provider Letter, posted on the FDA website, for further information about availability of supply.
"Sodium Bicarbonate is currently on the drug shortage lists of both the FDA and American Society of Health-System Pharmacists," stated Jeffrey Yordon, President, Chief Executive Officer and Chairman of the Board of Sagent. "We are pleased to provide a temporary source of this critical product to help address the current shortage, and we continue to advance long-term solutions to the overall drug shortage situation."
About Sodium Bicarbonate Injection, USP
Sodium Bicarbonate Injection is an electrolyte replenisher and systemic alkalizer. It is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. It is further indicated in the treatment of certain drug intoxications, in poisoning by salicylates or methyl alcohol, in hemolytic reactions requiring alkalinization of the urine to diminish nephrototxicity of blood pigments and in severe diarrhea which is often accompanied by a significant loss of bicarbonate.
Please refer to the US approved package insert, available at
www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm for the full prescribing information for 8.4% Sodium Bicarbonate Injection, USP (1 mEq/mL).
About Sagent Pharmaceuticals, Inc.
Sagent Pharmaceuticals, Inc., founded in 2006, is a specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectables. Sagent has created a unique global network of resources, comprising rapid development capabilities, sophisticated manufacturing and innovative drug delivery technologies, resulting in an extensive and rapidly expanding pharmaceutical product portfolio that fulfills the evolving needs of patients.