Aurobindo Pharma has received final approval from the U S Food and Drug Administration (US FDA) to manufacture and market metformin hydrochloride extended-release (ER) tablets USP 500mg and 750mg. (ANDA 079118). The product is ready for launch.

Metformin hydrochloride ER tablets USP 500mg and 750mg is the generic equivalent of Bristol Myers Squibb Company (BMS)’s Glucophage XR extended-release tablets 500mg and 750mg respectively. These tablets are oral anti-hyperglycaemic drugs indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type-2 diabetes.

The annual sale of the product is approximately US$ 230 million.

The product has been approved out of Unit III formulations facility in Hyderabad, India. Aurobindo now has a total of 153 ANDA approvals (127 final approvals including 1 from Aurolife Pharma LLC and 26 tentative approvals) from US FDA.