Aurobindo Pharma receives USFDA Approval for Saxagliptin Tablets, 2.5 mg and 5 mg

Aurobindo Pharma Limited 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 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.

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 822.30 as compared to the previous close of Rs. 837.05. The total number of shares traded during the day was 79656 in over 3793 trades.

The stock hit an intraday high of Rs. 841.10 and intraday low of 816.10. The net turnover during the day was Rs. 65692553.00.

Source : Equity Bulls

Keywords

AurobindoPharma INE406A01037 FinalApproval USFDA SaxagliptinTablets