In a bid to ease the ongoing shortage of chemotherapy in the US, the country’s Food and Drug Administration (FDA) has allowed for a temporary import of the cancer drug made in China.
Chinese drug maker Qilu Pharmaceutical has received the FDA approval for their cisplatin injections, CNBC reported.
The injectable medication will be distributed in the US in 50-milligram vials on a temporary basis by Canadian drug maker Apotex. It will be available for order by health care providers starting Tuesday.
“The FDA recognises the importance of a stable, safe supply of critical drugs used in oncology, especially those used in potentially curative or life-extending situations,” FDA Commissioner Dr Robert Califf said on Twitter.
“Today, we’ve taken steps for temporary importation of certain foreign-approved versions of cisplatin products from FDA-registered facilities and used regulatory discretion for continued supply of other cisplatin and carboplatin products to help meet patient needs.
“In these situations, we very carefully assess product quality and require companies to take certain measures to ensure the products are safe for patients. The public should rest assured that we will continue all efforts within our authority to help the industry that manufactures and distributes these drugs meet all patient needs for the oncology drugs impacted by shortages,” he noted.
Cisplatin, a generic drug available for decades in the US, has faced national shortage since February after an Indian pharmaceutical company temporarily halted production for the US market.
According to the US National Cancer Institute, Cisplatin and other platinum-based drugs are prescribed for 10 per cent to 20 per cent of all cancer patients. Cisplatin has a cure rate of over 90 per cent when used to treat testicular cancer. It also treats bladder, cervical, ovarian, lung, gastric, breast, and head and neck cancers.
The severe shortage of cisplatin and carboplatin, “the chemotherapy backbone”, is affecting hundreds of thousands of patients across the US, Dr. Amanda Fader, a professor at the Johns Hopkins School of Medicine, was quoted as saying to CNN.
Qilu’s version of cisplatin is not approved in the US. An FDA spokesperson said the agency assesses the quality of unapproved drug imports to make sure they are safe for US patients. At least 13 other cancer drugs are in short supply across the US.
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