Alerts

New FDA Warnings Possible for the DPP-4’s. See item #1 below. FDA Accepts Resubmitted Applications for Tresiba, Ryzodeg. More news coming soon.  

See Fact below.

FDA Approves a New Long-Acting Insulin. See this week’s Item #1. FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients. FDA Announcement

Sanofi and MannKind have announced that their inhaled insulin powder, Afrezza, is now available in the U.S. The product is administered via a small, portable inhaler to help boost glucose control in diabetes patients.

The Boehringer Ingelheim/Eli Lilly and Company combination SGLT2 inhibitor and DPP-4 inhibitor Glyxambi has been approved by the FDA. The empagliflozin/linagliptin combo is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when neither of the individual components are working as …

VBLOC Therapy is a first-in-class weight loss treatment that addresses the growing global health crises associated with obesity and its co-morbidities, such as diabetes and hypertension. Therapy is delivered by a pacemaker-like device called the Maestro® Rechargeable System controls both hunger and fullness by blocking the primary nerve which regulates …

See this week’s Item #1.

FDA Approves Liraglutide (Saxenda) for Weight Loss The U.S. Food and Drug Administration has approved Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity. See this week’s Item 11. "The approval of Saxenda adds a unique tool …

Eli Lilly has announced they are partnering with Adocia in a worldwide licensing collaboration focused on developing an ultra-rapid insulin, known as BioChaperone Lispro, which is currently in Phase Ib studies. 

See this week’s New Product: The Vibe Plus CGMS