Aurobindo Pharma gets USFDA approval for Saxagliptin tablets, plans immediate launch

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.
Source: TheHinduBusinessLine