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FDA Issues Draft Guidance for the Development and Approval of the Artificial Pancreas

The U.S. Food and Drug Administration (FDA) issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes. This step comes after a large campaign led by the Juvenile Diabetes research Foundation ...

FDA Grants Medtronic Approval to Conduct In-Home Study of Insulin Pump with Low Glucose Suspend

The U.S. Food and Drug Administration (FDA) has given Medtronic approval of its Investigational Device Exemption (IDE) to conduct a pivotal in-home clinical trial protocol for the ASPIRE (Automation to Simulate Pancreatic InsulinREsponse) study of the MiniMed Paradigm® System featuring Low Glucose Suspend (LGS) automation. FDA approval of the IDE makes Medtronic’s ASPIRE study the first in-home pivotal trial of a closed loop system for type 1 diabetes management...

FDA Approves Byetta for Use with Lantus Insulin in the U.S.

The U.S. Food and Drug Administration (FDA) has approved a new use for Amylin and Eli Lilly's type 2 diabetes drug, Byetta (exenatide) injection. Byetta is now approved as an add-on therapy to insulin glargine (Lantus), with or without metformin and/or a thiazolidinedione (TZD), for adults with type 2 diabetes...

Novo Nordisk Requests FDA Approval for Ultra-Long-Acting Insulin Degludec

Novo Nordisk filed two new drug applications for the approval of ultra-long-acting insulin degludec and the co-formulation, insulin degludec/insulin aspart (DegludecPlus) by the U.S. Food and Drug Administration. These new insulin analogs have been developed for the treatment of people with type 1 and type 2 diabetes.

FDA Advisory Committee Votes Against Type 2 Diabetes Drug Dapagliflozin

The U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting reached a decision regarding the New Drug Application, by The Bristol-Myers Squibb Company and AstraZeneca for the investigational compound dapagliflozin for treatment of type 2 diabetes...

Long Term Use of Diabetes Drug Actos May Increase Risk of Cancer

The U.S. Food and Drug Administration (FDA) issued a safety announcement informing the public that use of the type 2 diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines...

Novo Nordisk Issues Letter Reminding Healthcare Professionals of Victoza Risks

Novo Nordisk issued a letter reminding healthcare professionals of important safety information about the type 2 diabetes drug Victoza (liraglutide [rDNA origin]). The letter was issued because a recent assessment of healthcare providers showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza...

FDA Rejects Afrezza, Mannkind’s Inhaled Insulin

The FDA's Center for Drug Evaluation and Research has issued a complete response letter to Mannkind corp. regarding the New Drug Application (NDA) for Afrezza (insulin human [rDNA origin]) Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes...

Amylin and Eli Lilly Seek FDA approval for Expanded Use of Byetta in Type 2 Diabetes Patients

Amylin Pharmaceuticals, Inc.and Eli Lilly and Company have submitted a supplemental New Drug Application (sNDA) to the FDA for the expanded use of Byetta (exenatide) injection as an add-on therapy to basal insulin for adults with type 2 diabetes...

GSK Halts Enrollment in Avandia Study at FDA Request

GlaxoSmithKline confirmed today that it will suspend enrollment of new patients in the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) clinical trial at the request of the U.S. Food and Drug Administration (FDA) pending FDA review of recommendations from its Advisory Committee meeting July 13-14...