Aurobindo diabetes drug approved by US health regulator

Mon, 23 Jul 2012
Indian pharmaceutical company Aurobindo Pharma has been given the green light from the U.S. Food and Drug Administration (FDA) to manufacture and market its type 2 diabetes drug .

The firm has received final approval from the health regulator for the production and marketing of Metformin Hydrochloride extended release tablets in 500 mg and 750 mg strength.

The product, which is ready for launch, is an oral anti-hyperglycemic drug designed to improve blood glucose control in type 2 diabetics. It is the generic equivalent of Bristol Myers Squibb's Glucophage XR medication .

Aurobindo said the drug has been approved out of Unit-III formulations facility in Hyderabad, and has annual US sales of around $230 million.

The company added that it now has 127 final approvals and 26 tentative approvals from the FDA.
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