Aurobindo Pharma bags USFDA nod for Saxagliptin Tablets

Hyderabad: Aurobindo Pharma Limited has announced that the company has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Saxagliptin Tablets, 2.5 mg and 5 mg, which is to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Onglyza Tablets, 2.5 mg and 5 mg, of AstraZeneca AB.

Aurobindo is eligible for 180 days of shared generic drug exclusivity for Saxagliptin Tablets, 2.5 mg and 5 mg. The product is being launched immediately.

The approved product has an estimated market size of around US$ 101 million for the twelve months ending June 2023, according to IQVIA. Aurobindo now has a total of 466 ANDA approvals (439 Final approvals and 27 tentative approvals) from USFDA.

Saxagliptin Tablets, 2.5 mg and 5 mg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings.

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