Zydus Cadila gets USFDA nod for diabetes drug Dapagliflozin
Ahmedabad: Drugmaker, Zydus Cadila, has recently announced that the company has received tentative approval from the US Food & Drug Administration (USFDA) to market Dapagliflozin Tablets, 5 mg and 10 mg (US RLD: Farxiga Tablets).
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors.
Zydus Cadila is believed to be the only company with tentative approval that has submitted a paragraph IV certification for US Patent No. 6,515,117 that claims the Dapagliflozin compound.
The US District Court for the District of Delaware has scheduled a trial in February 2021 regarding Zydus Cadila's patent challenge.
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.
The group now has 311 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.
Read also: Zydus Cadila bronchospasm drug Albuterol gets USFDA approval
The company discovers, develops, manufactures, and markets a broad range of healthcare therapies.
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.