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FDA Allows Importation from Canada of Cefotaxime

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Article

Hikma, which makes the broad-spectrum antibiotic, has experienced manufacturing delays.

The FDA is allowing the temporary importation from Canada of SteriMax’s cefotaxime for injection. SteriMax, in conjunction with Provepharm Life Solutions and Direct Success, is coordinating with the FDA to increase the availability of the drug because of a shortage of cefotaxime in the United States.

Cefotaxime is a broad spectrum antibiotic used to treat pneumonia and cervicitis/urethritis.
The shortage is not related to increased demand, according to a spokesperson from the FDA.The U.S. manufacturer, Hikma, has had manufacturing delays and is not able to support the U.S. market. “Temporary importation was put in place to help address the shortage,” the spokesperson said in an email.

Hikma, according to the FDA’s shortage website, indicated that four of the company’s products are currently unavailable, and the shortage duration is unknown:

  • 500 mg/ 10 mL vial (NDC 0143-9930-10)
  • 1 g/ 10 mL vial (NDC 0143-9931-25)
  • 2 g/ 10 mL vial (NDC 0143-9933-25)
  • 10 g/ 100 mL vial (NDC 0143-9935-01)

Provepharm will be distributing two of SteriMax’s products:

  • Cefotaxime for Injection 1 g/vial with NDC 21586-011-2 (Canadian drug identification number 02434091)
  • Cefotaxime for Injection 2 g/vial with NDC 21586-012-2 Canadian drug identification number 02434105)

No other entity except Provepharm or Direct Success is authorized by the FDA to import or distribute the product.

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