[12 April 2013]
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 current contracted manufacturer of Amphotec is Ben Venue Laboratories. Ben Venue voluntarily suspended all manufacturing and distribution in mid-November, 2011 on a temporary basis. It is unknown when manufacturing will resume.
- 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 expected to be available from Alkopharma until after manufacturing is restored by Ben Venue Labs. Updated availability information from Alkopharma is not available.
April 12, 2013; February 13, 2013; September 10, 2012; July 6, 2012; February 15, 2012, University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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