Ranbaxy Laboratories has received approval from the USFDA to manufacture and market anti-diabetic drug Metformin Hydrochloride (Extended-Release) tablets of 750 mg.The office of generic drugs of USFDA has determined the company's formulation to be bio-equivalent and having the same therapeutic effect as that of the reference listed drug Glucophage.XR tablets 750 mg, the company said in a statement."This is a wonderful opportunity for Ranbaxy to introduce another affordable generic alternative to the US healthcare system. It also marks a major milestone as the 100th abbreviated new drug approval held by Ranbaxy allowing us to market another ethical product under the Ranbaxy label in the US," Jim Meehan, vice-president (sales and marketing) of Ranbaxy Pharmaceuticals Inc, said."Our plans are to introduce the product when quantities are sufficient to support market demand," he added.Merformin Hydrochloride extended release tablets, as monotherapy, are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes, the statement said.
