[02 January 2014]
Products Affected - Description
Amphotec, lyophilized powder, Alkopharma
50 mg vial (NDC 66435-0301-51)
100 mg vial (NDC 66435-0302-01)
Reason for the Shortage
- Kadmon had acquired Three Rivers Pharmaceuticals in October 2010 and Amphotec was part of the product portfolio.
- Kadmon recently sold Amphotec to Alkopharma. Alkopharma is the sole supplier of amphotericin b cholesteryl sulfate lipid complex. The contracted manufacturer of Amphotec was Ben Venue Laboratories.
- Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure.
- The shortage of amphotericin b cholesteryl sulfate lipid complex is not affecting other amphotericin formulations.
No presentations are available.
Estimated Resupply Dates
Amphotec is not available from Alkopharma. Contacts are unavailable to provide further availability.
January 2, 2014; October 9, 2013; July 11, 2013; April 12, 2013; February 13, 2013; September 10, 2012; July 6, 2012; February 15, 2012, University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.
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