Products Affected - Description
Tepadina, Adienne SA
15 mg vial, 1 count (NDC 53964-0001-01)
100 mg vial, 1 count (NDC 53964-0002-02)
Reason for the Shortage
- West-Ward Pharmaceuticals’ parent company, Hikma Pharmaceuticals, acquired several products from Bedford Laboratories in July 2014 including thiotepa injection. West-Ward is not actively marketing thiotepa injection at this time.
- FDA is allowing temporary importation of Tepadina (thiotepa), from Adienne Srl in Italy. Product may be ordered directly through Adienne Srl. The solution is similar in formulation to US thiotepa. The main differences between the two products are listed below:
- Tepadina comes in 15 mg and 100 mg vials while the US thiotepa from Bedford only comes in a 15 mg vial. Reconstitution of the products should still yield a final concentration of 10 mg/mL and therefore use caution in choosing vial size and volume of diluent.
- Tepadina is indicated for different uses and therefore different dosing regimens are on the Europe labeling compared to US labeling, but it is the same product as in the US.
- The bar coding for the Italian product will not provide correct information to bar code readers since the manufacturing code is not an NDC number. More information on the product packaging and ordering procedures can be found online.
- Adienne Srl is supplying Tepadina directly to hospitals and not through wholesalers. Orders can be placed directly with Adienne. Orders are shipped Monday through Wednesday to ensure product can arrive prior to the weekend to prevent temperature deviations.
- There are no other manufacturers of thiotepa for injection.
Insufficient supply for usual ordering.
Estimated Resupply Dates
West-Ward is not actively marketing thiotepa for injection.
May 4, February 6, 2015; November 10, 2014; September 22, 2014; July 30, 2014; May 19, 2014; March 24, 2014; January 14, 2014; November 6, 2013; September 23, 2013; September 18, 2013; July 18, 2013; May 24, 2014; March 25, 2013; January 30, 2013; November 28, 2012; September 25, 2012; August 30, 2012; August 21, 2012; July 12, 2012; June 20, 2012; May 15, 2012; March 5, 2012; January 4, 2012; December 1, 2011; October 20, 2011; September 29, 2011; August 31, 2011; July 28, 2011; June 29, 2011; June 1, 2011; Mat 20, 2011; May 2, 2011; April 18, 2011; March 30, 2011; March 22, 2011; March 1, 2010; November 17, 2009, University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.
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