Update on Propofol Shortage and Importation of Fresenius Propoven 1% (propofol 1%)
(March 16, 2010)
FDA Authorizes APP to Resume Importation of Fresenius Propoven 1% (propofol 1%) to Alleviate Ongoing Shortage of Propofol Injection in the United States
Due to the ongoing critical shortage of Propofol Injection in the United States, and in conjunction with the FDA, APP has been authorized to reintroduce Fresenius Propoven 1% (propofol 1%) to the US market. APP will also continue to offer DIPRIVAN® (propofol 1%) and increase supply of APP Propofol 1% (authorized generic DIPRIVAN).
FDA previously granted APP approval to import and distribute Fresenius Propoven 1% (propofol 1%) to help alleviate shortages following two voluntary recalls from other manufacturers of propofol injection. This temporary importation ended on February 1, 2010 and has now been reinstated to alleviate the ongoing shortage following continued supply issues from other manufacturers. APP has indicated that it is committed to providing the US market with available quantities of Fresenius Propoven 1% (propofol 1%), DIPRIVAN® (propofol 1%) and APP Propofol 1% (authorized generic DIPRIVAN®) and anticipates Fresenius Propoven (propofol 1%) will be used to address the shortage until the marketplace stabilizes. Fresenius Propoven 1% (propofol 1%) is manufactured by APP’s parent company Fresenius Kabi AG, in FDA compliant facilities.
Please see the following “Dear Healthcare Professional” letter or the FDA’s website for more information.
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For more information on the field of anesthesiology, visit the American Society of Anesthesiologists online at asahq.org . To learn more about the role physician anesthesiologists play in ensuring patient safety, visit asahq.org/WhenSecondsCount. Like ASA on Facebook , follow ASALifeline on Twitter and follow ASA on LinkedIn .