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Vercauteren, D

Section 7.2 directs monitoring the effects of concomitant oral medications and considering increased clinical or laboratory monitoring for drugs with a narrow therapeutic index

Vitamin D for the management of asthma

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Accordingly, as with a warning for gastroparesis, Defendants could have and should have warned of the risk of ileus in the labeling submitted for initial approval10 and strengthened the warnings in revised labeling through the CBE process