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.
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.