Aurobindo Pharma Limited has received final approval from the US Food and Drug Administration (USFDA) for manufacturing and marketing Saxagliptin Tablets in 2.5 mg and 5 mg strengths. These tablets are bioequivalent and therapeutically equivalent to the reference-listed drug (RLD) Onglyza Tablets, 2.5 mg and 5 mg, developed by AstraZeneca AB.
Aurobindo Pharma is eligible for 180 days of shared generic drug exclusivity for Saxagliptin Tablets.
The company has now accumulated a total of 466 ANDA (Abbreviated New Drug Application) approvals from USFDA, consisting of 439 Final approvals and 27 tentative approvals.
Saxagliptin Tablets, 2.5 mg and 5 mg are prescribed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus across multiple clinical settings. Aurobindo Pharma is set to launch the product immediately, further expanding its portfolio and presence in the diabetes care segment.