Alerts

FDA Restricts Lap-Band Claims “I lost 90 pounds with the Lap-Band” should also include that it has Serious Risks. FDA has warned eight surgical centers and a marketing firm in California about misleading advertising of the Lap-Band.

FDA Approves Sanofi’s iBGStar iPhone Glucose Monitor See Product of the Week below.

Medicare Pays for Intensive Obesity Counseling See this week’s Item #1, Medicare Now Pays for Intensive Obesity Counseling.

Sitagliptin/Pioglitazone Combo Application Withdrawn in EU Merck Sharp & Dohme Inc. has withdrawn its marketing authorization application for sitagliptin/pioglitazone (Janacti).

Lilly and Amylin Agree to End Partnership See this week’s Item #3, Lilly and Amylin Agree to End Diabetes Alliance.

New First in Class SGLT2 Drugs Hit a Stumbling Block FDA delays verdict on Astra/Bristol SGLT2 diabetes pill until Jan 28th, the same day they are deciding on the possible approval of Bydureon. See this week’s Item #4.

FDA Approves New Use for BYETTA® (exenatide) BYETTA is now approved as an add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione (TZD), in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone.  See …

Shortage of Apidra® There will be a temporary supply shortage of Apidra® SoloSTAR® pens in the US starting in late Oct. Due to the possible shortage, from now until April 30, 2012, Apidra vials will have NO CO-Pay for patients with commercial insurance.

Novo Nordisk has filed for regulatory approval of the ultra-long-acting insulins Degludec and DegludecPlus in Europe. According to their press release Novo will also be submitting both drugs to the FDA within two weeks. Both drugs will be available with a pen delivery system.

The Best from the 47th Annual Meeting of the European Association for the Study of Diabetes, Lisbon, Portugal. See all of our coverage on the 47th EASD from the details on the latest diabetes figures worldwide to the potential of a new Once-A-Year diabetes medication.