By Julie Steenhuisen and Michael Erman
Reuters – The U.S. Food and Drug Administration on Friday eased shortages of methotrexate, one of the most commonly used anticancer drugs, to boost two other rare chemotherapy drugs. announced that it is looking for a new supplier.
An FDA spokeswoman told Reuters the agency was looking at options for temporary imports of the drug, which has been in short supply since March.
According to the National Cancer Institute, methotrexate is an injection used to treat a wide range of cancers, ranging from childhood acute lymphoblastic leukemia, breast cancer, lung cancer, bone cancer, and certain types of head and neck cancer. is medicine.
Last week, the FDA announced it was seeking additional temporary suppliers for two other cancer chemotherapy agents, cisplatin and carboplatin. It has already signed a permit to market cisplatin manufactured by China’s Qilu Pharmaceutical Company in the country.
The FDA has not previously disclosed that it is also looking for new sources of methotrexate.
Some cancer drugs have been hit hard by continued shortages in the United States, prompting doctors to distribute drugs and complicating treatment plans for patients.
The supply comes from India-based manufacturer Intus Pharmaceuticals, which supplies the US market through its Accord Healthcare division, according to information released by US Senators Gary Peters and Debbie Stavenow. The disruption exacerbated the shortage, he said.
More than 130 formulations are currently in short supply in the United States, according to a list maintained by the FDA.
In the face of shortages, the FDA can make exceptions to allow products to be marketed outside of its normal oversight. A recent high-profile example is the opening up of the infant formula market to additional manufacturers.
Regulators typically require additional testing and oversight before approving new suppliers.
Asked about Qilu’s exemption, the regulator said in a statement, “The FDA may inspect the facility as an additional level of oversight and conduct FDA sampling and testing. In this case, the FDA is doing both. there is,” he said.
Methotrexate works by slowing or stopping the growth of cancer cells and by suppressing the immune system.
According to the American Association of Health System Pharmacists, suppliers with methotrexate injection shortages or backorders include Accord Healthcare, Fresenius Kabi, Pfizer, Teva, and Hikma Pharmaceuticals.
Methotrexate is also commonly used to treat autoimmune diseases such as rheumatoid arthritis.
(Reported by Julie Steenhuisen in Chicago and Michael Erman in New Jersey; edited by Bill Barclot)
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