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Once-daily colesevelam received approval to be mixed with fruit juice, diet soft drinks
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Daiichi Sankyo announced this week that the FDA approved a supplemental new drug application for colesevelam hydrochloride for oral suspension to be mixed with fruit juice or soft drinks, offering a new option for adults with type 2 diabetes and primary hyperlipidemia.
Colesevelam hydrochloride for oral suspension (Welchol, Daiichi Sankyo) was approved in 2009 to be mixed with water. According to a statement from the company, colesevelam hydrochloride is the only product approved by the FDA, in addition to diet and exercise, to improve both glycemic control and LDL levels in adults with type 2 diabetes and hyperlipidemia.
“We’ve seen that patients appreciate the flexible dosing options provided by Welchol, taken as tablets with a meal and liquid or as a drinkable formulation with a meal to help them reach their LDL and HbA1c goals,” Oliseyenum M. Nwose, MBBS, executive medical director, Medical Research and Strategy Therapeutic Areas Head, Hypertension and Metabolism, Daiichi Sankyo, stated in a press release. “We are pleased that patients, depending on their preference, can now choose to mix their Welchol for Oral Suspension with fruit juice, diet soft drinks or water.”
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