Aurobindo Pharma receives US FDA nod

Aurobindo Pharma has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market Metformin Hydrochloride Extended-Release (ER) Tablets USP 500 mg and 750 mg. (ANDA 079118). The product will be launched shortly.

Metformin Hydrochloride ER tablets USP 500 mg and 750 mg is the generic equivalent of Bristol Myers Squibb Company (BMS)’s Glucophage XR extended-release tablets 500 mg and 750 mg respectively. Metformin Hydrochloride ER Tablets are oral anti-hyperglycemic drugs indicated as an adjunct to diet and exercise to improve glycemic control in patients with type-II diabetes. The annual sale of the product is approximately $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  and 26 Tentative approvals) from US FDA.

EP News Bureau

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