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Imports of Injectable Nutrition Drugs Allowed to Counter Domestic Shortage

Friday, May 31, 2013
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration announced this week that it will allow an Illinois company to import from its Norway plant injectable drugs used in total parenteral nutrition that are in critical shortage in the U.S. TPN is an intravenous food solution used primarily to treat premature infants that contains several drugs that have been in short supply, including trace elements, potassium phosphate and sodium phosphate. According to the FDA, this shortage is largely the result of a decision by a large manufacturer of TPN products to temporarily shut down at the end of 2012 to address quality issues.

Drug shortages in the U.S. have been an increasing concern for the FDA, which has used its regulatory discretion to allow the importation of 14 drugs since 2010. FDA Commissioner Margaret Hamburg said the agency is using “every tool we have to resolve and prevent” this problem, such as providing expedited regulatory review and advice to manufacturers of drugs most in need.

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