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Diabetes / Health / Organochlorides / Bristol-Myers Squibb / Thiazolidinediones / Dapagliflozin / Metformin / Anti-diabetic medication / SLC5A2 / Medicine / Chemistry / Anti-diabetic drugs


FDA BRIEFING DOCUMENT NDA[removed]DAPAGLIFLOZIN TABLETS, 5 AND 10 MG
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Company

Renal Laboratory / Bristol-Myers Squibb/AstraZeneca / M.P.H. / BRISTOL-MYERS SQUIBB / /

Event

FDA Phase / /

MedicalCondition

cancers / breast cancers / cancer / disease / Urinary Tract Infection / hyperglycemia / Genital Infections / stroke / Genital Infection / Bladder Cancer / diabetes / unstable angina / Diabetes Mellitus / myocardial infarctions / moderately severe dapagliflozin-induced liver injury / bladder cancers / hypoglycemia / breast and bladder cancer / Breast Cancer / genitalurinary infections / /

OperatingSystem

OSE / /

Organization

Endocrinology Products Advisory Committee / Division of Metabolism and Endocrinology Products Through / M.P.H. Director office of Drug Evaluation / Food and Drug Administration / Endocrinology Products Office / Review Division / FDA / New Drugs Center for Drug Evaluation / Division of Metabolism / DEPARTMENT OF HEALTH / ADVISORY COMMITTEE / Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation / /

Person

Mary H. Parks / Ilan Irony / Somya V. Dunn / Silver Spring / Curtis J. Rosebraugh / Somya Dunn / D. Mary H. Parks / Jonathan Norton / Anita Abraham / /

Position

Director / M.D. Director / /

Product

pioglitazone / glipizide / DAPAGLIFLOZIN TABLETS / glimepiride / Pilot / T2DM / SGLT2 / dapagliflozin / /

ProvinceOrState

Maryland / /

URL

http /

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