米库氯铵是否在美国退市了?http://www.accessdata.fda.gov/sc ... ovalHistory#apphist Letter (PDF) 仿制药批准信息 We noted that the reference listed drug product (RLD) upon whichyou have based this application, Mivacron (Mivacurium Chloride)Injection, 2 mg (base)/mL, of Abbott Laboratories, is no longerbeing marketed in the United States. Thus, Abbott’s Mivacron(Mivacurium Chloride) Injection, 2 mg (base)/mL, was moved fromthe Active to the Discontinued section of the agency’spublication titled Approved Drug Products with TherapeuticEquivalence Evaluations, the “Orange Book”. Subsequently, in aFederal Register Notice dated August 8, 2007 (Volume 72, No.152), the agency announced its determination that Abbott’sMivacron (Mivacurium Chloride) Injection, 2 mg (base)/mL, wasnot withdrawn from sale for reasons of safety or effectiveness.This determination allows the agency to approve ANDAs for thediscontinued drug product. 其实自2006年开始2mg/ml的已经不在美国上市了。查看更多
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