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FDA Archives

FDA

Page 4
Type 1: FDA OKs Levemir for Two- to Five-Year-Olds

The US Food and Drug Administration has approved the use of Novo Nordisk's Levemir basal insulin for type 1 children aged two to five years. The FDA decision makes Levemir (insulin detemir [rDNA origin]) the only basal insulin approved for use in this age group.
Levemir, introduced to the US market in 2006, was previously approved for older children and adults with type 1 diabetes, as well as insulin-using type 2s.

Comments 0 comments - Jun 7, 2012 - * * * * *

Insulin degludec

Novo Nordisk's new variety of long-lasting insulin, insulin degludec, reduces low blood sugars while improving overall control, according to a pair of studies published in the prestigious journal The Lancet on April 27.

Comments 0 comments - May 8, 2012 - * * * * *

FDA Warns Diabetes Patients About Combining Aliskiren

On April 19, the US Food and Drug Administration issued a warning to diabetes patients not to combine the blood pressure medication aliskiren (Tekturna) with ACE inhibitors or angiotensin receptor blockers. The warning also applies to patients who have renal impairment.

Comments 0 comments - Apr 30, 2012 - * * * * *

FDA Gives Go-ahead to Bayer’s CONTOUR® Next EZ

The US Food and Drug Administration has okayed US sales of Bayer HealthCare's CONTOUR® Next EZ blood glucose monitoring system. The new BGM, currently available in other countries as the CONTOUR XT, will be available in the US market this summer.

Comments 0 comments - Apr 25, 2012 - * * * * *

Neuropathy Device Maker Files

NeuroMetrix, Inc., a Massachusetts-based medical device company, has filed a 510(k) form with the US Food and Drug Administration for the SENSUSTM, a pain therapy device for people who suffer diabetic neuropathy. A 510(k) is a "premarket notification" of a company's intent to market a medical product. The FDA then tests the product and provides feedback to the manufacturer. Once the FDA clears the product, its maker can introduce it to the US market.

Comments 0 comments - Apr 24, 2012 - * * * * *

FDA Says Levemir OK for Pregnant Women

The U.S. Food and Drug Administration says that Levemir is safe for use by pregnant women and does not increase the risk of harm to children in the womb.

Comments 0 comments - Apr 4, 2012 - * * * * *

Keep Your Fingers Crossed: FDA Approves Artificial Pancreas Outpatient Trial

The FDA has approved the start of outpatient trials of a smart phone-based monitoring device that functions as an artificial pancreas. If the device, which automatically measures blood glucose levels and adjusts them with insulin, is successful, several million type 1 patients could enjoy a whole new level of convenience.

Comments 9 comments - Mar 27, 2012 - * * * * *

ACP Guidelines Say Metformin Is the Best Starter Drug for Type 2s

The latest clinical guidelines for treating type 2 diabetes from the American College of Physicians (ACP) indicate that when diet, exercise, and weight loss fail to control blood sugar levels in early type 2 patients, physicians should prescribe metformin as the first drug therapy.

Comments 2 comments - Mar 1, 2012 - * * * * *

An Update on Bydureon

You've heard of the blockbuster drug Byetta, a daily injection for type 2 diabetes? Byetta's sister product, Bydureon, which is injected just once a week, has just been approved by the FDA and is available in pharmacies.

Comments 10 comments - Feb 17, 2012 - * * * * *

Diabetes and Anemia:

There are lots of articles about diabetes, as well as all kinds of information about anemia. But what if you have both? About 25 percent of people with diabetes have some level of anemia. This article explains how the two conditions interact.

Comments 3 comments - Feb 16, 2012 - * * * * *

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