Workers work on a production line at the factory of Qilu Pharmaceutical (Hainan) Co., Ltd. on Feb. 11, 2022 in Haikou, Hainan Province, China.
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The Food and Drug Administration Approved an unauthorized temporary importation Chemotherapy drugs from China in a drastic easing effort scarcity of Cancer drugs in United StatesAccording to a up to date Posted on the organization’s website on Friday.
Kilu Pharmaceuticalwhich manufactures and markets Cisplatin The injection was found in China FDA The export of that drug to the U.S. market was approved weeks ago, a document shows.
A letter dated May 24 from Kilur’s Deputy General Manager informed health-care professionals of the approval.
Kilu is coordinating with Apotex, a Toronto-based company, to distribute 50-mg vials of cisplatin in the US.
Health-care providers can begin ordering the drug through their wholesalers on Tuesday.
Cisplatin is a generic drug that has been available in the United States for decades and is distributed by several authorized manufacturers. Those manufacturers are unable to meet demand. The KILUR version of cisplatin is not approved in the United States
Qilu, headquartered in Jinan City, Shandong Province, is one of China’s 10 largest pharmaceutical manufacturers.
The FDA told CNBC this week that the agency is considering importing unapproved chemotherapy drugs. However, it did not at that time disclose the name of any manufacturer who could supply the drug.
An FDA spokeswoman said the agency evaluates the quality of unapproved drug imports to ensure they are safe for U.S. patients.
Doctors say some cancer patients may die if the shortage of national drugs like cisplatin is not addressed quickly. At least 13 other cancer drugs are in short supply in the United States
Cancer drug shortages have forced some hospitals to ration drugs to increase supplies by reducing doses and prioritizing patients who are most likely to recover.
Cisplatin is widely used to treat testicular, lung, bladder, cervical, and ovarian cancer, among other disease states. According to the National Cancer Institute, up to 20% of cancer patients are treated with cisplatin and other platinum-based chemotherapy drugs.
The World Health Organization says medicine is an essential part of basic health care.
A national shortage of cisplatin began in February after a pharmaceutical company based in India temporarily halted production for the US market.
Intus Pharmaceuticals decided to temporarily stop production last year after an FDA inspection found a “cascade of failures” at its quality control unit.
It is not clear when Intus will resume production of the drug for the US market.
An Intus spokeswoman told CNBC this week that the company is working with the FDA to resume production for the United States, but no date has yet been set.
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