Sagent starts temporary importation of sodium bicarbonate to US market
With the current critical shortage of Sodium bicarbonate injection, USP in the United States market, Sagent Pharmaceuticals, in cooperation with the US Food and Drug Administration (FDA), has started temporary importation of a non-US FDA approved 8.4 per cent Sodium Bicarbonate Injection (1 mEQ/mL) from Australian manufacturer, Phebra Pty Ltd., into the US.
"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."
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 diarrhoea which is often accompanied by a significant loss of bicarbonate.
Sagent Pharmaceuticals, Inc., is a specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectables.