Products Affected - Description
Tepadina injection, Adienne SA
15 mg, vial, 1 count (NDC 53964-0001-01)
100 mg, vial, 1 count (NDC 53964-0002-02)
Thiotepa lyophilized powder for solution for injection, West-Ward
15 mg, vial, 1 count (NDC 00143-9565-01)
Reason for the Shortage
- West-Ward launched thiotepa in August 2015.
- FDA was allowing temporary importation of Tepadina (thiotepa), from Adienne SA in Italy. There may still be product available at some healthcare centers but importation stopped in December 2015. 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.
There is insufficient supply for usual ordering
Estimated Resupply Dates
West-Ward has thiotepa available with an expiration date of < November 2017.
January 11, 2017; November 7, September 27, July 19, May 17, April 5 and 4, March 1, January 12, 2016; December 15, November 12, September 17, August 31, July 13, May 4, February 6, 2015; November 10, September 22, July 30, May 19, March 24, January 14, 2014; November 6, September 23 and 18, May 24, March 25, January 30, 2013; November 28, September 25, August 30 and 21, July 12, June 20, May 15, March 5, January 4, 2012; December 1, October 20, September 29, August 31, July 28, June 29 and 1, May 20 and 2, April 18, March 30 and 22, 2011; March 1, 2010; November 17, 2009, University of Utah, Drug Information Service. Copyright 2017, Drug Information Service, University of Utah, Salt Lake City, UT.
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