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Aurobindo Pharma bags USFDA nod for Saxagliptin Tablets
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.
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...
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.
Read also: Aurobindo Pharma arm bags USFDA nod for Plerixafor Injection
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751