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Dapagliflozin is used along with diet, exercise, and usually with other glucose-lowering medications, to improve glycaemic control in adults with type 2 diabetes. . Dapagliflozin, in addition to other SGLT2-inhibitors, was shown to reduce the rate of decline in kidney function and kidney failure in non-diabetic and type 2 diabetic adults when added to the existing treatment
Sotagliflozin (Inpefa) is a dual SGLT1/SGLT2 inhibitor approved by the US Food and Drug Administration (FDA) in May 2023, to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors.
Three drugs have been accepted by the Food and Drug Administration (FDA) in the United States; dapagliflozin, canagliflozin and empagliflozin. Canagliflozin was the first SGLT-2 inhibitor that was approved by the FDA, being accepted in March 2013. Dapagliflozin and empagliflozin were accepted in 2014.
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
[4] [5] It is a combination of dapagliflozin and metformin [4] and is taken by mouth. [4] Dapagliflozin/metformin was approved for use in the European Union in January 2014, [3] in the United States in February 2014, [5] [6] and in Australia in July 2014. [7]
[2] In the European Union, it is indicated in adults aged 18 years and older with type 2 diabetes: to improve glycemic control when metformin with or without sulphonylurea (SU) and either saxagliptin or dapagliflozin does not provide adequate glycemic control. [3] when already being treated with saxagliptin and dapagliflozin. [3]
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [ 1 ] and while there is no official list of PDUFA dates, [ 10 ] several websites collect PDUFA dates from press announcements in a calendar form.
In the European Union it is indicated in adults aged 18 years and older with type 2 diabetes: to improve glycemic control when metformin with or without sulphonylurea (SU) and either saxagliptin or dapagliflozin does not provide adequate glycemic control. [2] when already being treated with metformin and saxagliptin and dapagliflozin. [2]