Novo Nordisk Levemir gets CPMP okay
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Novo Nordisk expects European approval of Levemir (insulin detemir) "within the coming months" following a positive opinion from the EU's Committee on Proprietary Medicinal Products, the company announces Feb. 27. European launch is slated for second-half 2004. The long-acting insulin analog was deemed "approvable" for treatment of diabetes by FDA Oct. 7, 2003, pending resolution of "certain clinical issues" (1Pharmaceutical Approvals Monthly Nov. 1, 2003, p. 3)...
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