FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Dexrazoxane Injection
Status: Currently in Shortage
»Date first posted: 07/05/2017
»Therapeutic Categories: Oncology; Pediatric

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Clinigen Healthcare Ltd (Revised 07/26/2017)

Company Contact Information:
615-255-0068

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Cardioxane 500 mg Powder for Solution for Infusion (dexrazoxane hydrochloride); 1 vial (500 mg)(NDC 76310-002-01) Available to order 17 July; available to ship 28 July. Due to the current critical shortage of Dexrazoxane for Injection, 250 mg/vial and 500 mg/vial in the United States (U.S.) market, Clinigen Healthcare Ltd is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of Dexrazoxane for Injection 500 mg/vial. Clinigen Healthcare Ltd has initiated temporary importation into the U.S. of Cardioxane 500 mg Powder for Solution for Infusion (dexrazoxane hydrochloride) to help alleviate the shortage. The Cardioxane 500 mg Powder for Solution for Infusion was manufactured by Cenexi – Laboratoires Thissen S.A. in Belgium and is licensed for sale in the United Kingdom. Orders can be placed from 17 July 2017 with Clinigen Healthcare Ltd’s distributor for Cardioxane in the US, Cumberland Pharmaceuticals Inc., at 615-255-0068. Reference should be made to the Dear Healthcare Professional Letter for important information about the use of this product.

Dear Healthcare Professional Letter

Available
Totect® (Dexrazoxane) for injection; 1 vial (500 mg)(NDC 66220-110-01) Available to order 17 July; available to ship 25 July. Orders can be placed from 17 July 2017 with Clinigen Healthcare Ltd’s distributor for Cardioxane in the US, Cumberland Pharmaceuticals Inc., at 615-255-0068. Available

Mylan Institutional (Revised 09/12/2017)

Company Contact Information:
888-258-4199

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
250 mg Kit (NDC 67457-207-25) Intermittent supply. Demand increase for the drug
500 mg Kit (NDC 67457-208-50) Intermittent supply. Manually allocating emergency reserve. Demand increase for the drug

Pfizer Pharmaceuticals (Reverified 08/28/2017)

Company Contact Information:
844-646-4398

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Zinecard 250 mg Single-dose Vial (NDC 00013-8717-62) Next delivery and estimated recovery: Q4 2017 Shortage per Manufacturer: Manufacturing Delay Other
Zinecard 500 mg Single-dose Vial (NDC 00013-8727-89) Next delivery and estimated recovery: Q3 2018 Shortage per Manufacturer: Manufacturing Delay Other

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