Neurologist

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Drug Information Update – Questions and Answers on the Propofol Shortage

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation byFDA.


 

The U.S. Food and Drug Administration (FDA) is aware that recent shortages of propofol injection—a quick acting sedative-hypnotic used for the induction and maintenance of anesthesia or sedation—have resulted in significant concerns for some healthcare professionals in regard to patient care. The Agency has made every effort within its legal authority to address this problem. FDA has temporarily allowed the importation of Fresenius Propoven 1% into the United States. This propofol product is comparable to the product used in the United States and is currently approved in other countries. FDA is also working with the manufacturers of propofol products to try to prevent future shortages.

To view the Questions and Answers on the Propofol Shortage, please visit: Propofol

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May 14, 2010 - Posted by | Uncategorized

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