A employee works on the production line at the Qilu Pharmaceutical (Hainan) Co Ltd factory on February 11, 2022 in Haikou, Hainan Province, China.
Su Bikun | VCG | Getty’s paintings
The Food and Drug Administration authorized the temporary importation of an unapproved chemotherapy drug from China to alleviate the acute shortage of anti-cancer drugs in the United States. update published on Friday on the agency’s website.
Pharmaceutical Qiluwhich produces and sells cisplatinum injections in china, received FDA permission to export this drug to the US market a number of weeks ago, in line with the document.
A May 24 letter from Qilu’s deputy general manager notified health professionals of the approval.
Qilu partners with Toronto-based Apotex to distribute cisplatin 50mg vials in the US
Healthcare professionals can start ordering the drug from Tuesday through their wholesalers.
Cisplatin is a generic drug that has been available for a long time in the United States and distributed by several approved manufacturers. These manufacturers were unable to maintain up with demand. Qilu’s version of cisplatin just isn’t approved in the US
Qilu, which is headquartered in Jinan City, Shandong Province, claims to be one of the top 10 drug manufacturers in China.
The FDA told CNBC this week that the agency is considering importing unapproved chemotherapy drugs. But at the time, the names of the manufacturers that may supply the drug weren’t disclosed.
An FDA spokesperson said the agency assesses the quality of imported unapproved drugs to make sure they’re secure for U.S. patients.
Doctors say some cancer patients could die if the national shortage of drugs like cisplatin just isn’t resolved soon. A minimum of 13 other cancer drugs are in brief supply in the United States
Cancer drug shortages have forced some hospitals to ration drugs by reducing the dose to extend supply and prioritizing patients who usually tend to be cured.
Cisplatin is widely utilized in the treatment of testicular, lung, bladder, cervical and ovarian cancers, in addition to other conditions. In keeping with the National Cancer Institute, as much as 20% of cancer patients are treated with cisplatin and other platinum-based chemotherapy drugs.
The World Health Organization says medicine is a vital part of primary health care.
The national cisplatin shortage began in February after an Indian-based pharmaceutical company temporarily halted production for the US market.
Intas Pharmaceuticals decided to temporarily halt production after an FDA inspection found a “cascade of failures” in its quality control unit last yr.
It just isn’t known when Intas will resume production of the drug for the US market.
A spokesperson for Intas told CNBC this week that the company is working with the FDA to restart production in the US, but no date has been set yet.