The Japanese drug manufacturer Daiichi Sankyo has received approval for its supplemental new drug application Welchol (colesevelam HCl) for oral suspension from the Food and Drug Administration (FDA) in the United States.
Welchol for oral suspension is taken in conjunction with either a diet soft drink or fruit juice, and can be prescribed for adult patients with type 2 diabetes or primary hyperlipidemia .
Welchol is also intended to help improve low-density lipoprotein (LDL, or so-called bad cholesterol) and glycaemic control when it is taken in combination with diet and exercise by adult patients with high LDL cholesterol and type 2 diabetes, the only drug approved by the FDA that does this.
Oliseyenum Nwose, head of medical research and strategy therapeutic areas hypertension and metabolism at Daiichi Sankyo, commented "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-C and A1C goals."
He added "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. Welchol for Oral Suspension is once-daily, sugar-free, citrus-flavored and non-systemically absorbed, which means it is not metabolized in the liver or kidneys ."
Welchol diabetes drug approved by FDA
Thu, 28 Jul 2011
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