The US Food and Drug Administration has approved Glucophage XR(metformin HCl extended release tablets) 750mg tablet, a new dosage strength of one of the firm's leading products.
Glucophage XR was launched in a 500mg formulation in October 2000 for use together with diet and exercise as initial drug therapy to improve glycemic control for adults 17 years and older with type 2 diabetes, when diet and exercise are not enough. The new formulation is intended to allow a hike in dose in patients who do not respond to the lower dose and, like its 500mg counterpart, may also be used in combination with a sulfonylurea or insulin to improve glycemic control.
The Glucophage XR range was developed to help B-MS protect its lucrative market for the immediate-release version of the drug, which has since lost patent protection.
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