Bloomberg News, July 11: U.S. regulators have allowed the import of an anticancer drug from China to secure additional supplies. The drug is currently facing a nationwide shortage in the United States, which has forced doctors to ration it and put patients' lives at risk.
FDA Spokesperson Says Agency Approved 10 Additional Batches of Cisplatin from Qilu Pharmaceutical for Distribution on Monday, After Four Batches Were Previously Authorized. Report Indicates Qilu's Version Has Not Yet Been Approved in the U.S., but Is Similar to Cisplatin Drugs Approved for Sale in the Country.
On May 31 this year, Qilu Pharmaceutical Group published an article on its official WeChat account stating that in March, Qilu Pharmaceutical received an urgent email from the FDA. The email indicated a shortage of Cisplatin Injection in the U.S. market. Qilu Pharmaceutical, which exports more than 20 formulated products to the U.S. with nearly half ranking first in sales, was given priority inquiry for supply capability. Qilu Pharmaceutical swiftly completed document preparation, translation, and proposal submission. Subsequently, the FDA initiated a fast-track approval process and approved Qilu Pharmaceutical's Cisplatin Injection for export to the U.S. on May 23. Qilu Pharmaceutical stated that this marks the first time a Chinese pharmaceutical company has supplied a drug in shortage to the U.S. using a product sold in the Chinese domestic market.