FDA's Interim Limits for NDMA and NDEA in Angiotensin II Receptor Blockers (ARBs)

FDA’s Interim Limits for NDMA and NDEA in Angiotensin II Receptor Blockers (ARBs)

By PharmaCompass

2018-12-27

Impressions: 1,196 Article

Drug	Maximum Daily Dose (mg/day)	Acceptable Intake NDMA (ng/day)*	Acceptable Intake NDMA (ppm)**	Acceptable Intake NDEA (ng/day)*	Acceptable Intake NDEA (ppm)**
Valsartan	320	96	0.3	26.5	0.083
Losartan	100	96	0.96	26.5	0.27
Irbesartan	300	96	0.32	26.5	0.088
Azilsartan	80	96	1.2	26.5	0.33
Olmesartan	40	96	2.4	26.5	0.66
Eprosartan	800	96	0.12	26.5	0.033
Candesartan	32	96	3.0	26.5	0.83
Telmisartan	80	96	1.2	26.5	0.33

* The acceptable intake is a daily exposure to a compound such as NDMA or NDEA that results in a 1:100,000 cancer risk after 70 years exposure
** These values are based on a drug's maximum daily dose as reflected in the drug label

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