Novo Nordisk Levemir gets CPMP okay
This article was originally published in Pharmaceutical Approvals Monthly
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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