FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

CDER Features Valsartan in Report on Drug Safety Priorities for 2018

Jan. 15, 2019
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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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