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BY OUR PHARMA CORRESPONDENT
1 August, 2005: The Indian pharmaceutical major, Ranbaxy Laboratories Limited has received tentative approval from the US Food and Drug Administration to manufacture and market glimepiride tablets in 3 mg and 6 mg strengths.
Ranbaxy’s glimipiride is the generic version of Amaryl, marketed by Aventis Pharma (now sanofi-aventis).
According to IMS figures, total annual market sales for Amaryl tablets (were $336.6 million (+22.4%).
Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin-dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycaemia 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 hyperglycaemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycaemic agent. Combined use of glimepiride and insulin may increase the potential for hypoglycaemia, Ranbaxy said in a press statement.
Glimepiride Tablets, 1, 2 and 4 mg strengths are available through the innovator company. The company will offer these tablet strengths, as well as 3, 6, and 8 mg that are additional strengths developed through Ranbaxy's R&D organization. Product will be launched following final approval from the FDA on October 6, 2005, the release said.
BY OUR PHARMA CORRESPONDENT
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