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PARSIPPANY, N.J. — The Food and Drug Administration has approved a new means of administration for a drug made by Daiichi Sankyo, the drug maker said Monday.
Daiichi Sankyo announced the FDA approval of Welchol (colesevelam hydrochloride) for oral suspension to be mixed with fruit juice or diet soft drinks. The drug, used to improve blood-sugar control and cholesterol levels in patients with Type 2 diabetes and high cholesterol, received approval in 2009 for mixing with water.
“Since the approval of once-daily Welchol for oral suspension, 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 cholesterol] and A1C goals,” Daiichi Sankyo medical director for medical research and head of strategy therapeutic areas Oliseyenum Nwose said. “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.”