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 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
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.