Aurobindo Pharma 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 (AstraZeneca).
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 $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.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
