The FDA has approved the first generic versions of AstraZeneca's Farxiga (dapagliflozin) tablets.
Dapagliflozin is taken by adults with type 2 diabetes mellitus who either already have cardiovascular disease or present multiple risk factors for cardiovascular disease. The sodium-glucose cotransporter 2 (SGLT2) inhibitor reduces the risk of hospitalization from heart failure. It improves glycemic control by reducing how much glucose and sodium the kidneys are able to reabsorb. Patients take the tablets in conjunction with improvements to diet and exercise.
The FDA granted approvals for multiple generics, including 5 mg and 10 mg tablets from companies like Cipla, Inventia Healthcare, and Biocon Pharma. The medication is also approved in combination with other drugs, including with metformin hydrochloride (in extended release tablets) and with saxagliptin hydrochloride, both with and without metformin hydrochloride.