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FDA Authorizes Importation of Propofol to Address Shortage

November 17, 2009

In response to recent shortages of propofol and other induction agents, the FDA, in consultation with ASA, the propofol manufacturer APP, and other stakeholders, has released the following statement on the importation of propofol. Please note there are important formulation and labeling differences between U.S. manufactured propofol and Fresenius Propoven 1% injection from the European Union. Therefore, individuals are encouraged to read the statement provided by APP to familiarize themselves with the differences.

Dear Colleague,
As part of its efforts to resolve a critical shortage of propofol 1% injection products, FDA has authorized the importation of Fresenius Propoven 1% injection from the European Union, until such time that sources within the United States are capable of meeting local demand.  Attached is the Propofol Importation Statement. 

A Dear Healthcare Professional letter from APP Pharmaceuticals, A Company of the Fresenius Kabi Group, is being distributed with the product and will be posted on the FDA website; a copy of the letter is attached.

Updated information can be obtained at the following FDA website:   http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm

Healthcare professionals may report serious adverse events (side effects) concerning drug products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.  Please include the name of the product, the manufacturer, and lot number (if known).

Online:  MedWatch Online Voluntary Reporting Form (3500)
Regular Mail: Download postage-paid FDA Form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: (800) FDA-0178
Phone: (800) FDA-1088

Sincerely,
Beth Fritsch, RPh, MBA
Office of Special Health Issues
Food and Drug Administration
Beth.Fritsch@fda.hhs.gov

FDA Propofol Importation Statement
APP Statement: Important Differences in Formulation and Labeling