FDA lifts import ban on Chinese API to prevent shortages

Generics/General | Posted 18/03/2016 post-comment0 Post your comment

The US Food and Drug Administration (FDA) has lifted its ban on one of the active pharmaceutical ingredients (APIs) from China-based Zhejiang Hisun Pharmaceutical (Hisun) due to a ‘critical drug shortage concern’.

Drug shortages V13C22

On 18 February 2016, FDA revised its import alert notification to allow Hisun to import cancer drug daunorubicin. 

Hisun is still under an import alert, initiated in September 2015, which means that all other API products from the company are banned entry to the US. The import ban came three months before a warning letter, which cited the company for failure to prevent unauthorized access or changes to data, and failure to provide adequate controls to prevent manipulation and omission of data. 

The originator product is marketed in the US as Cerubidine (daunorubicin hydrochloride). The product is an anticancer (antineoplastic or cytotoxic) chemotherapy drug and is used to treat acute myelogenous leukaemia (AML) and acute lymphoblastic leukaemia (ALL). It belongs to a class of drugs known as anthracyclines and works by slowing or stopping the growth of cancer cells. 

FDA announcement states that ‘only the API Daunorubicin HCl (NDC 58623-0046) for the Daunorubicin liposomal application (NDA# 50704) has a critical drug shortage concern’ and should be ‘excluded from (DWPE) [Detention without Physical Examination]. FDA adds that ‘shipments destined to any other manufacturer should be detained as per the Import Alert’, stating as the reason problems with Good Manufacturing Practices (GMP). 

Drug shortages remain a major problem for FDA. Most drug shortages involve generic, sterile injectables; in 2011, these accounted for 73% of all reported drug shortages [1]. 

The action for daunorubicin has been taken temporarily, according to an FDA spokeswoman, in order to prevent a possible future shortage. The drug has been in short supply in the past – a situation that was resolved in 2015. 

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1.   GaBI Online - Generics and Biosimilars Initiative. Drug shortages linked to quality control costs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 18]. Available from: www.gabionline.net/Pharma-News/Drug-shortages-linked-to-quality-control-costs

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Source: US FDA

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