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Pharmaceuticals / Regulatory Affairs

CDER Features Valsartan in Report on Drug Safety Priorities for 2018

Jan. 15, 2019

CDER released its latest annual report on drug safety priorities, detailing how it approached drug safety in 2018 — including how it handled the valsartan impurity crisis.

The report includes a timeline for the FDA’s response to the valsartan crisis that began in June and notes that the agency continues to investigate and test all angiotensin-receptor blockers (ARBs) for the presence of NDMA and NDEA and is taking swift action when it identifies the impurities at above-acceptable levels.

Among other events in the valsartan timeline, the agency noted recalls of batches of valsartan containing NDEA by Teva and Mylan.

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