Aurobindo Pharma Limited on Tuesday announced that it 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), the company announced through an exchange filing.
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.
Aurobindo Pharma Limited shares
The shares of Aurobindo Pharma Limited on Tuesday at 2:00 pm IST were at ₹821.30, down by 0.12 percent.
(We are on WhatsApp. To get latest news updates, Join our Channel. Click here)
