[24 May 2013]
Products Affected - Description
Thiotepa for Injection, Bedford
15 mg/mL vial (NDC 55390-0030-10)
Reason for the Shortage
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:
- Bedford has thiotepa injection on shortage due to manufacturing delays. Bedford anticipates full availability of each presentation the company reintroduces to market.
- Ben Venue voluntarily entered into a consent decree with FDA in late-January 2013 which allows Ben Venue to manufacture over 100 medications as long as they are compliant with the decree. Ben Venue supplies multiple products for Bedford Laboratories, a division of Ben Venue.
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. The ordering information can be found online.
There are no other manufacturers of thiotepa for injection.
- 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.
There are no presentations readily available.
Estimated Resupply Dates
Bedford has thiotepa for injection on back order and the company cannot estimate a release date.
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 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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