IOH Diabetes FDA Warnings, Recalls, Approvals 2006

FDA Approves New Treatment for Diabetes - Source: FDA Approves New Treatment for Diabetes - First in a New Class of Diabetes Drugs, FDA Press Release, October 17, 2006. The Food and Drug Administration (FDA) announced the approval of Januvia (sitagliptin phosphate) Tablets, the first diabetes treatment approved in a new class of drugs known as DDP-4 inhibitors that enhances the body's own ability to lower elevated blood sugar. FDA approved Januvia for use in addition to diet and exercise to improve blood sugar levels in patients with type 2 diabetes, alone or in combination with two other commonly prescribed oral diabetes medications, metformin or a PPAR (peroxisome proliferator-activated receptor gamma) agonist, when either of these drugs alone, along with diet and exercise, don't provide adequate blood sugar control. Read full FDA release 10/17/2006

Diamyd's Type 1 diabetes drug shows efficacy - Diamyd Medical has announces that its lead drug candidate, Diamyd, has demonstrated overall statistically significant efficacy in preserving insulin production in a phase II clinical trial in 70 children and adolescents with type 1 diabetes. 08/29/2006

FDA to Review Merck Diabetes Drug Filing - Merck & Co's new drug application for MK-0431A, an investigational oral medicine combining Januvia with metformin for type 2 diabetes, has been accepted for standard review by the FDA. 08/02/2006

FDA Approves Duetact(TM) (pioglitazone HCl And Glimepiride) For The Treatment Of Type 2 Diabetes - Takeda PharmaceuticalsNorth America, Inc. (TPNA) announced that the U.S. Food and DrugAdministration (FDA) has approved the New Drug Application (NDA) forduetact(TM) (pioglitazone HCl and glimepiride), pronounced "Duet Act," forthe treatment of type 2 diabetes. 08/01/2006

FDA approves Takeda's diabetes combo - Takedas US subsidiary has received FDA approval for its new drug application for Duetact in type 2 diabetes. 08/01/2006

FDA Approves Takeda's Diabetes Combo - Takeda's US subsidiary has received FDA approval for its new drug application for Duetact in type 2 diabetes. Duetact combines Actos (pioglitazone HCl) and glimepiride, two widely used diabetes medications with complementary actions, in a single tablet. 07/31/2006

FDA Approves duetact(TM) (pioglitazone HCl and glimepiride) for the Treatment of Type 2 Diabetes - Takeda Pharmaceuticals North America, Inc. announced that the U.S. Food and Drug Administration has approved the New Drug Application for duetact , pronounced "Duet Act," for the treatment of type 2 diabetes. 07/31/2006

NicOx moves diabetes drug into phase II - Following promising results in previous trials, NicOx SA has opted to move NCX 4016 forward in clinical development as a novel insulin sensitizing agent for the treatment of type 2 diabetes. 07/28/2006

New Diabetes Drug Approved - A new drug that could change the way millions of people with diabetes manage their disease may hit the market as early as this week. 07/17/2006

New Diabetes Drug Approved - A new drug that could change the way millions of people with diabetes manage their disease may hit the market as early as this week. NewsCenter 5's Liz Brunner reported Monday that Pfizer's Exubera was approved by the FDA in January. It is the first insulin that you can inhale. But already, doctors are getting questions about who should try it and who should not. 07/17/2006

FDA Approves Avandamet(R) (rosiglitazone Maleate And Metformin HCl) As Inital Therapy In The Treatment Of Type 2 Diabetes - GlaxoSmithKline announced today FDA approval of Avandamet (R) (rosiglitazone maleate and metformin HCl) for use as initial treatment of type 2 diabetes as an adjunct to diet and exercise. Avandamet was previously approved as a second-line therapy - it was indicated for use in patients who were uncontrolled on metformin monotherapy. 07/16/2006

Disetronic Medical Systems Inc. Recalls Power Packs used in D-TRONplus Insulin Pumps - Source: Disetronic Medical Systems Inc Announces a Voluntary Nationwide Recall of Disetronic D-TRONplus Power Packs used in D-TRONplus Insulin Pumps , Firm Press Release, July 13, 2006. Disetronic Medical Systems Inc. (Disetronic) of Fishers, IN announced a recall of the Disetronic D-TRONplus Power Packs, that power the D-TRONplus Insulin Pump. There is the real potential that the power pack could shut down the D-TRONplus Insulin Pump without any warning. If a shut down occurs, insulin delivery is interrupted. An interruption in insulin delivery may lead to uncontrolled diabetes mellitus, resulting in hyperglycemia, which may lead to serious patient injury and/or death. This is an Urgent Device Correction notification to health care professionals and their patients not requiring product removal at this time. If you are a physician or a patient who has experienced a problem with any Disetronic D-TRONplus Power Packs, please notify Disetronic at 1-800-688-4578. Read full FDA release 07/13/2006

GlaxoSmithKline Diabetes Drug Receives FDA Approval As Initial Therapy - Avandamet, a diabetes drug from GlaxoSmithKline, can now be used as an initial treatment for type 2 diabetes. 07/12/2006

Glaxo resumes sale of diabetes drug - GlaxoSmithKline P.L.C. said yesterday that it would resume sales and promotion of its diabetes drug Avandamet after making government-ordered repairs at a plant and getting expanded approval for its use. 07/12/2006

FDA approves new Glaxo diabetes drug - Drug-maker GlaxoSmithKline announced Tuesday that the federal government has approved one of its diabetes drugs for use as a front-line treatment. 07/12/2006

Glaxo diabetes drug approved as first-line treatment - GlaxoSmithKlines diabetes drug Avandamet has been approved by the FDA for use as a first-line treatment of type 2 diabetes as an adjunct to diet and exercise. 07/12/2006

Merck & Co: planning to reap sweet rewards in diabetes - Merck & Co has revealed plans to file for FDA approval of MK-0431A in 2006, potentially enabling it to overtake Novartis in the race to commercialize the first DPP-4 inhibitor. The news is also of particular significance to Mercks diabetes pipeline following its failure to successfully launch a drug in the dual PPAR class. 06/08/2006

MediaFact Launches Section On Zyprexa and Diabetes - MediaFact (http://www.mediafact.com), an online resource for information on health care issues related to hazardous occupational exposure and drug side effects, has published a new section on Zyprexa and diabetes. Zyprexa (olanzapine), manufactured by Eli Lilly and Company, is a widely prescribed antipsychotic drug used for the treatment of schizophrenia and manic depression. Evidence now suggests that Zyprexa is linked to the development of diabetes in a significant number of patients. 06/08/2006

Warning over faulty diabetes aid - BBC News - Regulators warn diabetes patients a fault in vital equipment could put them at risk of an overdoes of insulin. 06/08/2006

(AFX UK Focus) 2006-06-05 14:58 GMT: Merck to file Januvia diabetes type II drug in 2006; earlier than expected - Merck & Co Inc said it expects to file a new drug application for its type 2 diabetes drug Januvia to the Food and Drug Administration in 2006, earlier than its initially anticipated 2007 date. 06/05/2006

GENFIT Initiates Phase II Clinical Trials With GFT14 To Tackle Cardiometabolic Risk - Phase I results revealed very good tolerance in healthy volunteers as well as an excellent security profile for GFT14, one of the medical candidates that GENFIT is developing to tackle cardiometabolic risk. 05/03/2006

Boca Medical Products Recalls Insulin Syringes - Source: Boca Medical Products, Inc. Issues Nationwide Recall of Insulin Syringe Product, Firm Press Release, April 13, 2006. Boca Medical Products, Inc. is initiating a recall of Ultilet Insulin Syringe 30g 1/2cc product lot number 5GEXI as displayed on the inner case. The product is being recalled because of possible bacterial presence of Bacillus cereus and Staphylococcus intermedius. This presents a risk of local infection due to soft tissue injection with a contaminated syringe as well a risk of introduction of contaminating organism into previously sterile vial. The introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels. Consumers who have Ultilet Syringe Insulin product lot 5GEXI, should stop usage and return the specific product. For any question related to the case consumers should call 1-800-354-8460. Read full release 04/13/2006

Disetronic Medical Systems, Inc. Announces a Recall Of All ACCU-CHEK™ Ultraflex Infusion Sets - Source: Disetronic Medical Systems, Inc. Announces a Voluntary Nationwide Recall Of All ACCU-CHEK™ Ultraflex Infusion Sets, Firm Press Release, April 3, 2006. Disetronic Medical Systems, Inc, (Disetronic) announced a voluntary nationwide recall of all ACCU-CHEK™ Ultraflex Infusion Sets, because of a potential that tubing could fully or partially separate at the luer lock-tubing connection. In the event that a full or partial separation occurs, it is possible that insulin could leak from the infusion set tubing causing an interruption of insulin delivery, which can cause hyperglycemia. This recall applies to all ACCU-CHEK™ Ultraflex infusion sets. Patients using any standard luer-lock insulin pump may also be using these ACCU-CHEK™ Ultraflex infusion sets. Disetronic is advising customers to check their infusion sets at the luer lock-tubing connection at least every 3 hours and before bedtime. Customers also have the option of replacing their ACCU-CHEK™ Ultraflex infusion sets with ACCU-CHEK™ Tender, or ACCU-CHEK™ Rapid-D infusion sets. Customers that have fully or partially separated tubing sets, or wish to discontinue use of their ACCU-CHEK Ultraflex Infusion Set may call Disetronic Medical Systems Pump Support at 1-800-688-4578 for replacement. Read full FDA release 04/03/2006

FDA Approves Inhaled Insulin for Treatment of Diabetes - Source: FDA Approves First Ever Inhaled Insulin Combination Product for Treatment of Diabetes, FDA Press Release, January 27, 2006. The Food and Drug Administration has approved the first ever inhaled insulin. Exubera, an inhaled powder form of recombinant human insulin (rDNA) for the treatment of adult patients with type 1 and type 2 diabetes, is the first new insulin delivery option introduced since the discovery of insulin in the 1920s. Read full FDA release 01/27/2006

Roche Diagnostics Issues a Recall of Some ACCU-CHEK® Aviva Meters - Source: Roche Diagnostics Issues a Worldwide Voluntary Recall of Some of its ACCU-CHEK® Aviva Meters , Firm Press Release , January 16, 2006 . Roche Diagnostics has initiated a worldwide voluntary recall of specific ACCU-CHEK Aviva Meters because of the potential for an electronic malfunction which can cause the meter to report an erroneous result or shut down and no longer be used. The recall includes U.S. serial numbers 52500000000 through 52510999999. In the U.S. people with diabetes, health care professionals, pharmacists, and distributors have been instructed that if they have a meter with these serial numbers, they should contact 1-888-591-5084 for a product replacement. The recall does not apply to meters with U.S. serial numbers 52511000000 and higher or ACCU-CHEK Aviva test strips. Outside the U.S. , the recall includes serial numbers 52600000000 through 52610999999, 52700000000 through 52710999999, and 52800000000 through 52810999999. Customers outside the U.S. have also been notified. Read full FDA release 01/16/2006



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