According to the FDA and a triumphant tweet from FDA Commissioner Robert Califf, the shortage of the cancer drug cisplatin that began in February of last year has been resolved.
The supply issues for cisplatin, a chemotherapy used to treat a wide range of cancers, were caused by manufacturers not investing their production capacity and drug companies depending on one supplier for raw ingredients, according to remarks made last year by Richard Pazdur, director of the FDA’s Oncology Center of Excellence.
Intas Pharmaceuticals, a cisplatin manufacturer based in India, was also hit with a negative Form 483 in 2023 that cited cleaning violations and manipulated documents.
“Since the shortage was announced last year, we’ve taken strategic steps within our statutory authority to tackle cancer drug supply issues,” Califf wrote Friday on X.
As part of that strategy, the FDA imported cisplatin from China-based Qilu Pharmaceutical last year that was then distributed by Apotex in the US.
“The FDA will continue to work with drug manufacturers, supply chain companies, health systems and clinicians, including pharmacists, to help restore access to essential cancer treatments and other medicines that are currently in short supply,” Califf wrote.