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Home » Metozolv Needs REMS, Black Box Warning, FDA Says
Metozolv Needs REMS, Black Box Warning, FDA Says
March 6, 2009
The FDA is requiring Wilmington Pharmaceuticals to have a risk evaluation and mitigation strategy (REMS) and add a black box warning to labeling as a condition for approving its gastrointestinal drug Metozolv, which has metoclopramide as its active ingredient.