An fda advisory committee recommended against approving the drug at a july meeting by a 96 vote, citing concern over potential breast and bladder cancer risks dapagliflozin is an. Reviewed by judith stewart bpharm last updated on may 6, 2020. Drug name and strengths farxiga dapagliflozin tablets, 5. At a july 2011 advisory committee meeting to discuss dapagliflozin, the panel had voted 96 against. Canagliflozin, dapagliflozin warnings strengthened by fda. Farxiga dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus see clinical studies. Statement on a nonproprietory name adopted by the usan council efficacy and safety of dapagliflozin, added to therapy of patients with type 2 diabetes with inadequate glycemic control on insulin. Dapagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes.
A federal advisory committee voted 9 to 6 on tuesday that a firstofitskind diabetes drug should not be. Controlling high blood sugar helps prevent kidney damage, blindness, nerve. To view other topics, please sign in or purchase a subscription. Dapagliflozin is a small molecule drug for reducing blood glucose and treating. Product information for auspar xigduo xr dapagliflozin as propanediol monohydrate metformin hydrochloride astrazeneca pty ltd pm20151515 date of finalisation 17 december. Dapagliflozin was rejected by the fda in january 2012 because of concerns about its riskbenefit profile. Dapagliflozin is the international nonproprietary name inn, and the united states adopted name usan. Type 2 diabetes drug dapagliflozin rejected by fda. Fda briefing document endocrine and metabolic drug. The effect of dapagliflozin is an increased glucosuria, and it was shown that mean blood glucose concentrations and postprandial glucose excursion in special were significantly reduced in type 2.
Fda rejects dapagliflozin for type 2 diabetes medpage today. Advisory committee meeting december 12 december 6, 20. Dapagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Persons with disabilities having problems accessing the pdf files below may call 301 796. Established name saxagliptin and dapagliflozin fixed combination drug product. Dapagliflozin, manufactured by bristolmyers squibb and astrazeneca. Addendum to fda briefing document advisory committee meeting december 12 20 for dapagliflozin.
Drug name, active ingredients, strength, dosage formroute, marketing status, te code, rld, rs. Dapagliflozin is 78% bioavailable and rapidly absorbed. The fda has strengthened its drug label warnings about the risk for acute kidney injury in patients taking canagliflozin or dapagliflozin for type 2 diabetes. The food and drug administration has approved the entry of dapagliflozin, a drug for treating type 2 diabetes, into the u. Endocrine and metabolic drug advisory committee meeting. The committee will discuss supplemental new drug application snda 204629. Fda oks dapagliflozin as type 2 drug diabetes health. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for.
Dapagliflozin ist ein oral zu applizierendes antidiabetikum zur behandlung des typ2diabetes. Bristolmyers squibb application no 202293 approval date. May increase to 10 mg qday in patients tolerating 5 mgday who. Dapagliflozin farxiga is an oral medication used to improve glycemia blood glucose control in patients with type 2 diabetes. Dapagliflozin impurities synthink research chemicals. Dapagliflozin is a sodiumglucose cotransporter sglt2 inhibitor. European public assessment report epar for forxiga dapagliflozin pdf. When combined with diet and exercise in adults, dapagliflozin helps to improve glycemic control by.
Dapagliflozin is a sodiumglucose cotransporter 2 inhibitor indicated for managing diabetes mellitus type 2. Dapagliflozin is an oral diabetes medicine that helps control blood sugar levels. Food and drug administration fda has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin invokana. Dapagliflozin is dosed starting at 5 mg orally in the morning and can be titrated up to 10 mg orally in the morning if clinically indicated.
Indicated as an adjunct to diet and exercise to improve glycemic control with type 2 diabetes mellitus t2dm initial. Dapagliflozin will lower a1c levels by an average of 0. It acts as a sodiumglucose cotransporter 2 sglt2 inhibitor. Dapagliflozin side effects, dosage, interactions drugs. There is a combination product dapagliflozinmetformin extendedrelease, called xigduo xr. Fda approved indications dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in patients with t2dm. Dapagliflozin resubmitted to fda diabetes in control. Farxiga is indicated 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, and as an.
Chairman and members of the endocrinologic and metabolic. Dapagliflozin is a derivative of naturally occurring dihydrocholine glucoside. Farxiga dapagliflozin dosing, indications, interactions. Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Division of medication error prevention and analysis.
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