Sunday, July 31, 2005
Ranbaxy gets temporary FDA nod
RANBAXY Laboratories Ltd has received tentative approval from the US Food and Drug Administration to manufacture and market glimepiride tablets, 3 mg and 6 mg used for treatment of diabetes. The total annual market sales for Aventis Pharmaceuticals' Amaryl tablets were $336.6 million. Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with non-insulin-dependent (Type II) diabetes mellitus whose hyperglycemia cannot be controlled by diet and exercise alone.