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Diabetes, Type 2 News (Page 18)
Related terms: Noninsulin-dependent Diabetes, Type 2 Diabetes, Diabetes, Type 2
FDA Approves Synjardy XR (empagliflozin/metformin hydrochloride extended-release) for Adults with Type 2 Diabetes
RIDGEFIELD, Conn. and INDIANAPOLIS, Dec. 12, 2016 /PRNewswire/ – The U.S. Food and Drug Administration (FDA) has approved Synjardy XR (empagliflozin and metformin hydrochloride extended-release)...
FDA Approves Jardiance (empagliflozin) to Reduce Cardiovascular Death in Adults with Type 2 Diabetes
December 2, 2016 – The U.S. Food and Drug Administration today approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2...
Sanofi Receives FDA Approval of Soliqua 100/33 (insulin glargine and lixisenatide) for the Treatment of Adults with Type 2 Diabetes
PARIS, Nov. 21, 2016 /PRNewswire-USNewswire/ – Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved once-daily Soliqua 100/33 (insulin glargine & lixisenatide injection)...
Novo Nordisk Receives FDA Approval for Xultophy 100/3.6 (insulin degludec and liraglutide injection) for Type 2 Diabetes
PLAINSBORO, N.J., Nov. 21, 2016 /PRNewswire/ – Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application for...
FDA Approves Invokamet XR (Canagliflozin/Metformin Hydrochloride Extended-Release) for the Treatment of Adults with Type 2 Diabetes
RARITAN, N.J., September 21, 2016 – Janssen Pharmaceuticals, Inc. (Janssen) announced today the U.S. Food and Drug Administration (FDA) has approved Invokamet XR - a once-daily, fixed-dose c...
FDA Medwatch Alert: GlucaGen HypoKit (glucagon [rDNA origin] for injection) by Novo Nordisk Inc: Recall - Detached Needles on Syringe
ISSUE: Novo Nordisk Inc. is recalling six batches of the GlucaGen HypoKit in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile...
Sanofi Receives FDA Approval of Adlyxin (lixisenatide) for Treatment of Adults With Type 2 Diabetes
PARIS, July 27, 2016 /PRNewswire/ – Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Adlyxin (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection...
FDA Expands Indication For Type 2 Diabetes Treatment Synjardy (Empagliflozin/Metformin Hydrochloride) To Include Treatment-Naïve Adults
RIDGEFIELD, Conn., and INDIANAPOLIS, July 19, 2016 /PRNewswire/ – The U.S. Food and Drug Administration has approved an expanded indication for Synjardy (empagliflozin and metformin hydrochloride)...
FDA Medwatch Alert: Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings
ISSUE: FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). ...
FDA Approves Once-Daily Jentadueto XR (linagliptin and metformin hydrochloride extended-release) for Type 2 Diabetes
Ridgefield, Conn., and Indianapolis, May 31, 2016 – The U.S. Food and Drug Administration (FDA) has approved Jentadueto XR (linagliptin and metformin hydrochloride extended-release) tablets for the t...
FDA Expands Indication of Invokamet (canagliflozin/metformin HCl) to Include First-Line Treatment of Type 2 Diabetes
RARITAN, N.J., May 24, 2016 – Janssen Pharmaceuticals, Inc. (Janssen), today announced the U.S. Food and Drug Administration (FDA) has approved Invokamet, a fixed-dose combination therapy of I...
FDA Medwatch Alert: Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Clinical Trial Results Find Increased Risk of Leg and Foot Amputations
ISSUE: FDA is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with...
FDA Medwatch Alert: Metformin-containing Drugs: Drug Safety Communication - Revised Warnings for Certain Patients With Reduced Kidney Function
ISSUE: FDA is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. The c...
FDA Medwatch Alert: Diabetes Medications Containing Saxagliptin and Alogliptin: Drug Safety Communication - Risk of Heart Failure
ISSUE: An FDA safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or...
U.S. Food And Drug Administration Approves Humulin R U-500 KwikPen
INDIANAPOLIS, Jan. 21, 2016 /PRNewswire/ – The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's Humulin R U-500 KwikPen (insulin human injection) 500 units/mL, a...
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