FDA Turns to China During Chemo Drug Crisis

Banned Chinese drugmaker allowed to ship API to help with shortage.

Feb 23rd, 2016

The FDA updated its ban against a Chinese drugmaker, because of a chemo drug shortage.

Zhejiang Hisun Pharmaceutical can now ship daunorubicin HCl, which is "used in the injected med DaunoXome, which in addition to Kaposi's sarcoma is used to treat specific types of leukemia and non-Hodgkin lymphoma," according to FiercePharma Manufacturing.

The FDA made the revision to their own ban because of a "critical drug shortage concern," the news outlet reported.

Last year the FDA banned 15 drugs from the same company.

"When FDA exempts certain drugs from an import alert due to shortage concerns, the agency also often requests the manufacturer to take certain measures to enhance quality oversight for products that are offered for entry into the United States," an FDA spokesman told Regulatory Focus, according to FiercePharma Manufacturing.

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Saleable Returns Enforcement Delayed to 2020

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