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A cancer-drug shortage in the United States has led to the collaboration between China’s Qilu Pharmaceutical and the U.S. Food and Drug Administration (FDA), which has begun importing the drugmaker’s generic cancer treatment, cisplatin.
Qilu Pharmaceutical’s cisplatin injections are marketed and manufactured in China and have not received FDA approval in the U.S.
“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,” FDA Commissioner Dr. Robert Califf said.
Qilu received permission from the agency to export its drug to the American market in late May, a document shows, amid a growing cisplatin shortage that could potentially risk the survival of hundreds of thousands of cancer patients in the U.S.
The scarcity cisplatin in the U.S. was solidified last November, when U.S. inspectors identified “widespread problems” at India’s Intas Pharmaceuticals, which had been responsible for producing more than half the U.S. supply of the potent generic cancer treatment.
The manufacturing of cisplatin requires the metal platinum, and a sterile production environment and measures to protect lab workers.
There are currently more than 130 drug formulations in shortage in the United States, according to a list maintained by the FDA.
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Copyright © 2023 CGTN. 京ICP备16065310号
Disinformation report hotline: 010-85061466