Alerts

FDA Looking at Making Diabetes Drugs Available Over the Counter See this week’s Item #3, Diabetes and Statin Meds to Be Available without a Prescription.

Artificial Pancreas Works For three days a 12 year old girl with Type 1 diabetes wore a CGMS and a special pump with insulin and glucagon. She ate whatever she wanted and the device worked perfectly, adjusting her insulin and glucagon needs every 5 minutes. JDRF is funding the artificial …

FDA Panel Votes in Favor of Weight Loss Drug Qnexa An FDA advisory panel has voted 20-2 to recommend approval of the weight-loss drug Qnexa, but urged the agency to require a post-approval trial to monitor for cardiovascular side effects.

Bydureon is now available in pharmacies. Medicare Update: The 28% cut in physician payments scheduled to begin March 1 will be postponed and/or will be offset by cuts in the budget.

FDA Approves Third New Diabetes Drug within Last 7 Days See this week’s Item #3 for information on the third new drug approved by the FDA recently. Diabetes Prevention a Waste of Resources? See this week’s Item #4.

FDA Approves Second New Diabetes Drug within Three Days Bydureon was the first to be approved, now find out what the second new drug is. (See this week’s Item #3.)

Bydureon Approved for Sale in the US FDA approves Bydureon as adjunct treatment of type 2 diabetes. In a letter posted to the Food and Drug Administration website, the FDA said that Bydureon was approved as an adjunct to diet and exercise to improve glycemic control in adults with type …

FDA Issues Response Letter on Dapagliflozin The FDA has issued a complete response letter regarding the New Drug Application for investigational compound dapagliflozin (SGLT2) for the treatment of type 2 diabetes in adults. The complete response letter requests additional clinical data to allow a better assessment of the benefit-risk profile …

Warning Letter Issued by FDA to J&J for Delayed Reporting for Insulin Pump Problems See this week’s Item #11.

Antibodies Holds Keys to Diabetes Breakthrough See this week’s Item #3.