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Diabetes, Type 2 News (Page 24)

Related terms: Noninsulin-dependent Diabetes, Type 2 Diabetes, Diabetes, Type 2

Novo Nordisk Receives FDA Approval of Tresiba (insulin degludec) for Use in Children and Adolescents With Diabetes

PLAINSBORO, N.J., Dec. 19, 2016 /PRNewswire/ – Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for...

FDA Medwatch Alert: Pioglitazone-containing Medicines: Drug Safety Communication - Updated FDA Review, Increased Risk of Bladder Cancer

ISSUE: As a result of an updated review, the FDA has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an...

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...

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