Warning Letter Bulletin - DDMAC UNTITLED LETTERS: 7615W.
Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, April 16 (DDMAC). A journal ad and a sales aid for Micardis (telmisartan) tablets, submitted via Form 2253, were deemed misleading for implying superiority over other angiotensin II receptor blockers, insufficient contextual information for a pie chart and a graph that presented clinical data inaccurately.
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FDA also objected to the use of …
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