East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Dapagliflozin and Metformin Hydrochloride Extended- Release Tablets, 5 mg/ 500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg. Aurobindo Pharma’s Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Xigduo XR Tablets, manufactured by AstraZeneca AB (AstraZeneca).

Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets are indicated as :

• An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.