FDAnews Drug Daily Bulletin
Jan. 28, 2008
| Vol.
5 No.
18
WelChol Gains Type 2 Diabetes Indication
The FDA has approved Daiichi Sankyo’s cholesterol treatment WelChol for the improvement of glycemic control in adults with Type 2 diabetes. The company said this medication is the first to be approved for lowering both glucose and LDL cholesterol levels. The approval is for the drug’s use in combination with metformin, sulfonylureas or insulin, the company said. Labeling states that WelChol (colesevelam HCl) has not been tested as a single agent or in combination with a dipeptidyl peptidase-4 inhibitor, such as Merck’s Januvia (sitagliptin). The product had sales of $217 million during the firm’s 2006 fiscal year ending March 2007. |
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