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Post by Penny on Oct 9, 2009 1:53:33 GMT -5
fdanews.com/newsletter/article?issueId=13008&articleId=120432FDA Approves Metozolv With REMS, Warning The FDA has approved Wilmington Pharmaceuticals’ Metozolv with a risk evaluation and mitigation strategy (REMS) to treat symptoms of acute and recurrent diabetic gastroparesis in adults and for 4- to 12-week therapy of adults with documented symptomatic gastroesophageal reflux disease who have not been helped by conventional therapy. The agency had sent a complete response letter to Wilmington with the REMS as a condition of approval a day after the FDA announced it would require all makers of drugs containing metoclopramide to have a REMS and add a black box warning to labeling.
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