The US Food and Drug Administration (FDA) is maintaining its reliance on China-based Qilu Pharmaceutical for supplies of the essential chemotherapy drug, cisplatin. Following the initial import of four lots in May, an additional ten lots have been approved this month. The drugs are distributed by Canada-based Apotex and are anticipated to arrive within a week, as initially reported by Bloomberg and Fierce Pharma.
Addressing the US Drug Shortage Crisis
The current shortage of cisplatin in the US can be traced back to an FDA inspection of a single factory that raised quality concerns. This has resulted in a lack of manufacturing capacity for the drug, forcing doctors to ration supplies. Cisplatin is a standard of care chemotherapy agent used as a monotherapy or in combination with other treatments for various cancers, including bladder, ovarian, and testicular cancers.
Qilu Pharmaceutical’s Role in Alleviating the Shortage
Qilu Pharmaceutical first secured approval for its version of cisplatin in China in 2002. The company’s ability to meet the FDA’s approval standards and supply requirements highlights its role in alleviating the drug shortage in the US. The continued approval of additional shipments underscores the importance of international pharmaceutical cooperation in ensuring patient access to critical medications.-Fineline Info & Tech
