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news.Ranbaxy Pharmaceuticals has received approval from the FDA to manufacture and market Glimepiride tablets, a generic equivalent of Aventis Pharmaceuticals' Amaryl tablets for the treatment of type II diabetes.
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According to figures cited by the company, total annual market sales for Amaryl tablets were $349.5 million.
Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin-dependent (type II) diabetes mellitus whose hyperglycemia cannot be controlled by diet and exercise alone.
Glimepiride is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycemic agent.
“We are pleased to receive this final approval for Glimepiride Tablets. This product represents an interesting opportunity for Ranbaxy, in which we will offer a number of strengths of this oral hypoglycemic agent to support dosing flexibility that will benefit both prescribers and patients,” said Venkat Krishnan, vice president, Ranbaxy.