Hyderabad, Apr 7 (TNT): Aurobindo Pharma Limited on Tuesday said it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in multiple strengths.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug Xigduo XR of AstraZeneca, Hyderabad-based pharmaceutical company said in a release here.
The tablets will be manufactured at Unit-IV of APL Healthcare Limited, its wholly owned subsidiary, and will be launched immediately.
According to industry estimates, the approved product has a market size of about $514 million for the 12 months ending February 2026.
The comapny said it has a total of 579 ANDA approvals from the USFDA, including 554 final approvals and 25 tentative approvals as of March 31, 2026.
The company, being among the first ANDA applicants with a substantially complete filing and Paragraph IV certification for this product, is eligible for 180 days of shared generic drug exclusivity.
The combination drug is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with Type-2 diabetes mellitus where treatment with both dapagliflozin and metformin is appropriate.
TNT KS
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