FDA’s top generic drug official urges firms to complete nitrosamine risk assessments

BETHESDA, MD — Iilun Murphy, the director of the US Food and Drug Administration’s Office of Generic Drugs (OGD), issued a warning to manufacturers regarding a recently identified leachable nitrosamine in certain drug products that are packaged in infusion bags.

She stressed that manufacturers of affected products must conduct thorough risk assessments to confirm that their bags do not contain this substance. These risk assessments are required to be completed by 16 November 2025.

Murphy made these remarks on 27 October at the Association of Accessible Medicines (AAM) GRx+Biosim meeting.

These nitrosamines have been observed in infusion bag packaging, such as printed overwraps and products with inks and nitrocellulose. The concern is that this nitrosamine, identified as N-nitrosodibutylamine (NDBA), a small-molecule nitrosamine impurity, may leach into these products.

FDA originally announced this in an August 2025 paper titled “Emerging Scientific and Technical Information on Leachable NDMA and Other Small-Molecule Nitrosamines in Infusion Bags.” In the paper, the FDA urges manufacturers to conduct risk assessments and test at least three batches of their infusion products by 16 November. These findings must then be reported to FDA.

Nitrosamine impurities have raised concerns among regulators worldwide since their discovery in valsartan medications in 2018. Although nitrosamines occur naturally in very small quantities, they are classified as potential carcinogens.

Murphy also reiterated that the agency will give drugmakers more time to conduct testing for other types of nitrosamine drug substance-related impurities (NDSRIs) found in approved pharmaceuticals after extending the 1 August 2025 deadline. Manufacturers will need to submit progress reports during this extended period. (RELATED: FDA extends deadline for nitrosamine testing submissions, Regulatory Focus 24 June 2025)

Murphy also addressed the status of generic drug approvals, highlighting some notable achievements. She mentioned that in FY 2025, FDA approved or tentatively approved 939 abbreviated new drug applications (ANDAs). This total included the approval of 125 complex generics, 92 first-time generic drug approvals, and 107 generics designated as competitive therapeutic alternatives.

In 2025, the FDA approved several notable first generics for drugs that had previously lacked generic competition. These include liraglutide injection for chronic weight management, iron sucrose injection for treating iron deficiency anemia in patients with chronic kidney disease or on dialysis, sitagliptin combined with metformin for type 2 diabetes, rivaroxaban as an anticoagulant, and siponimod for the treatment of multiple sclerosis.

Murphy also announced that the FDA has selected two applicants to participate in its pilot program for Abbreviated New Drug Application (ANDA) prioritization pilot. This initiative is meant to enhance US drug manufacturing and testing for generic drug manufacturers. Under the program, ANDA applicants who conduct bioequivalence testing in the US and source their Active Pharmaceutical Ingredients (APIs) domestically will be eligible for priority review.

FDA’s top generic drug official urges firms to complete nitrosamine risk assessments

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