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Diabetes, Type 2 News (Page 19)
Related terms: Noninsulin-dependent Diabetes, Type 2 Diabetes, Diabetes, Type 2
FDA Approves Basaglar (insulin glargine) for Type 1 and Type 2 Diabetes
December 16, 2015 – The U.S. Food and Drug Administration today approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric...
FDA Medwatch Alert: Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - FDA Eliminates the Risk Evaluation and Mitigation Strategy (REMS)
ISSUE: FDA is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines, which are approved as Avandia, Avandamet, Avandaryl, and generics....
FDA Medwatch Alert: SGLT2 Inhibitors: Drug Safety Communication - Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections
ISSUE: An FDA safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of...
FDA Medwatch Alert: Invokana and Invokamet (canagliflozin): Drug Safety Communication - New Information on Bone Fracture Risk and Decreased Bone Mineral Density
ISSUE: FDA has strengthened the warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures, and added new information about decreased...
FDA Approves Synjardy (empagliflozin/metformin hydrochloride) for Type 2 Diabetes
RIDGEFIELD, Conn. and INDIANAPOLIS, Aug. 27, 2015 /PRNewswire/ – The U.S. Food and Drug Administration (FDA) has approved Synjardy (empagliflozin and metformin hydrochloride) tablets, from...
FDA Medwatch Alert: DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain
ISSUE: The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and...
FDA Medwatch Alert: SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood
ISSUE: FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood...
Sanofi Receives FDA Approval of Once-Daily Basal Insulin Toujeo
PARIS, Feb. 25, 2015 – Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily long-acting basal...
FDA Approves Glyxambi (empagliflozin and linagliptin) for Type 2 Diabetes
RIDGEFIELD, Conn. and INDIANAPOLIS, Feb. 2, 2015 – The U.S. Food and Drug Administration (FDA) has approved Glyxambi (empagliflozin/linagliptin) tablets, from Boehringer Ingelheim Pharmaceuticals, I...
FDA Approves Xigduo XR (dapagliflozin and metformin hydrochloride) for Type 2 Diabetes
WILMINGTON, Del., October 30, 2014 – AstraZeneca today announced that the U.S. Food and Drug Administration has approved once-daily Xigduo XR (dapagliflozin and metformin hydrochloride...
FDA Approves Trulicity (dulaglutide) for Type 2 Diabetes
September 18, 2014 – The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with...
FDA Approves Invokamet (canagliflozin/metformin) for Type 2 Diabetes
RARITAN, N.J., August 8, 2014 – Janssen Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration (FDA) has approved Invokamet, a fixed dose therapy combining canagliflozin and m...
FDA Approves Jardiance (empagliflozin) to Treat Type 2 Diabetes
August 1, 2014 – The U.S. Food and Drug Administration today approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2...
FDA Approves Afrezza to Treat Diabetes
June 27, 2014 – The U.S. Food and Drug Administration today approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes...
FDA Medwatch Alert: Olmesartan: Drug Safety Communication - FDA Review Finds Cardiovascular Risks for Diabetics Not Conclusive
Includes: Benicar, Benicar HCT, Azor, Tribenzor, and Generics [Posted 06/24/2014] ISSUE: FDA has completed its safety review and has found no clear evidence of increased cardiovascular risks...
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