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FDA Takes Action to Ease Neonatal Drug Shortage

Federal health regulators will allow overseas imports of a critical intravenous drug formula used to nourish premature infants, amid a shortage that has impacted hospitals nationwide.

The Food and Drug Administration says new supplies of the injectable drug, total parenteral nutrition, will be available to U.S. patients this week. The agency is temporarily allowing imports from a plant in Norway to ease shortages triggered by the shutdown of American Regent, the drug’s primary U.S. manufacturer.

American Regent halted operations late last year to fix contamination issues uncovered by FDA inspectors. Regulators found a number of problems at the company’s facility, including specs of matter floating in injectable drugs.

Hospitals across the U.S. use parenteral nutrition formula to feed infants who are unable to eat or drink.

 

Copyright 2013 The Associated Press.

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