Alerts

FDA Won’t Approve Statin-Fenofibrate Combo: The FDA said it won’t approve a new combo capsule for dyslipidemia until it learns more about the safety and efficacy of the compound, a decision that may be linked to the FDA’s review of the ACCORD trial findings.  AgaMatrix and sanofi-aventis sign a long-term …

Important new information about the OneTouch® PingTM Glucose Management System, Animas® 2020, 1250, and 1200 Insulin Pumps: We have learned of several cases in which pumpers have accidentally delivered excessive insulin when they ignored pump warnings and did not disconnect from their infusion set before loading the pump cartridge. In …

Zocor (simvastatin) — increased risk of muscle injury with high doses: FDA has notified healthcare professionals and patients that, based on review of data from a large clinical trial and other sources, there is an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering …

FDA Delays Mannkind Diabetes Inhaled Insulin Approval: The FDA has delayed the approval of an inhaled insulin drug and device from MannKind. The FDA asked MannKind to provide updated data on the safety and efficacy of its Afrezza device and additional information about the inhaler used to deliver the insulin …

David Joffe, BSPharm, CDE, FACA Amylin, Lilly and Alkermes received a Complete Response Letter from FDA for Exenatide Once Weekly. New drug to be called BYDUREON (exenatide for extended-release injectable suspension).  

  Ninety-two Percent of Pre-Diabetes Patients Are Unaware of their Status See this week’s Item #4. FDA Panel Sees User Errors with Insulin Pumps. See this week’s Item #12.  

Diabetes Vaccine This Decade. See this week’s Item #3. Diabetes Diagnosis to Soar with A1c Switch for Diagnosis. See this week’s Item #1.

Early Pregnancy Weight Gain Linked to Diabetes. See this week’s Item #2. LifeScan Recalls Specific Lots of Consumer and Professional OneTouch(R) SureStep(R) Test Strips Due To Inaccurate Readings at High Levels. See Press Release here. Amylin announced that the FDA has extended the PDUFA date for Byetta LAR from March …

Senate Report Links Diabetes Drug Avandia to Heart Attacks. The diabetes drug Avandia is linked with tens of thousands of heart attacks, and drugmaker GlaxoSmithKline knew of the risks for years but worked to keep them from the public, according to a Senate committee report released Saturday. The 334-page report …

Normal Glucose Greater than 85mg/dL in Kids Predicts Diabetes Later. See this week’s Item #2. Key To Reversing Type 1 Diabetes Discovered. See this week’s Item #9.