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Metozolv Needs REMS, Black Box Warning, FDA Says
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. The agency sent its complete response letter to Wilmington a day after announcing it would require all makers of drugs containing metoclopramide to have a REMS and a black box warning.
Washington Drug Letter |
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