January 23, 2013
FDA Provides Update Regarding Ongoing Propofol Shortage: Teva to Restart Production
ASA continues to work with the Food and Drug Administration (FDA) to prevent and mitigate drug shortages. Captain Valerie Jensen, R.Ph, the FDA's associate director for the Center for Drug Evaluation and Research's Drug Shortage Program offered the following update regarding propofol shortages:
"FDA continues doing everything in our regulatory authority to address this shortage. We are continuing the importation of Propoven and we anticipate seeing steady improvements in supply of propofol and Diprivan over the next couple of months. Fresenius/APP has increased production and shipments of the product and Teva is expected to be releasing product by end of February. Teva had discontinued this drug in 2010 and they have responded to this shortage by reentering the market with this critical drug.
We are also anticipating some relief with etomidate in the coming weeks as production is increasing to meet the shortfall. We know that anesthesia drugs have been severely impacted by ongoing shortage issues and we will continue doing all we can to address these shortages and will continue to update supply information on our CDER Drug Shortage page on these drugs as information becomes available. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm"