Amneal Initiates Temporary Import of Cancer Drug Due to Shortage

Although it contains the same strength as Bleomycin Sulfate, the FDA does not approve this product's distribution
Although it contains the same strength as Bleomycin Sulfate, the FDA does not approve this product's distribution

Amneal Biosciences announced that due to the current shortage of Bleomycin Sulfate for Injection, USP, 15 Units and 30 Units per vial, they have initiated a temporary importation of Bleomycin Sulfate Powder for Injection 15,000 IU per vial to the market. Each vial contains 15,000 IU of Bleomycin Sulfate Powder for Injection, which is equivalent to Bleomycin Sulfate USP 15 units (1000 IU of Bleomycin Sulfate Powder for Injection = 1 unit of Bleomycin Sulfate USP). Prescribers and pharmacists must be alert to this difference in labeled units in order to prevent medication errors.

The imported product was manufactured by Cipla Ltd. from their FDA-inspected facility in Verna, Goa, India for Amneal Pharma Australia Pty Ltd; it was sold under the Willow Pharmaceuticals label. The products contain Lot # GE50604, GE60003, and GE60012. 

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Currently, only Amneal Biosciences is authorized to import or distribute Amneal Pharma Australia's Bleomycin Sulfate Powder for Injection 15,000 IU product. The FDA has not approved this specific product being distributed in the United States but it does contain the same active ingredient and the same strength as the approved Bleomycin Sulfate for Injection, USP, 15 Units per vial. 

Bleomycin Sulfate for Injection is approved for the treatment of squamous cell carcinoma, non-Hodgkin lymphoma, testicular carcinoma, Hodgkin lymphoma, and malignant pleural effusion. The two major differences between the U.S. and Australia package inserts is the use of different units and the Amneal Australia label does not include an indication for malignant pleural effusions. Also, the U.S. label provides weight-based and body surface area (BSA)-based dosing whereas the Australia product label provides only BSA-based dosing.

The barcode used for the Bleomycin Sulfate Powder for Injection 15,000 IU may not be properly recognized by certain scanning systems. Healthcare institutions should confirm that the barcode systems do not provide incorrect data when the product is scanned. Other methods should be followed to ensure use of the correct drug product.

For more information call (855) 266-3251 or visit Amneal.com.

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