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FDA Archives

FDA

Page 3
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 2 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 24 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 12 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 - * * * * *

An Inside View of Barley Beta Glucan

Barley has more beta glucan fiber than any other grain, and it has repeatedly established positive clinical results with regard to diabetes control. It not only boosts immune function by supporting macrophages and neutrophils, lowers blood pressure and cholesterol levels, and helps control obesity, but also attenuates postprandial glucose levels, improves insulin sensitivity, and promotes a feeling of satiety.

Comments 6 comments - Feb 5, 2012 - * * * * *

FDA Gives Long-Awaited Nod to Amylin’s Bydureon

After several years of delays and setbacks, Amylin Pharmaceuticals has received FDA approval to begin US marketing of BydureonTM. The first once-a-week type 2 therapy to be offered in the US market, Bydureon is expected to be available by February. Amylin says that its wholesale price will be about $4,200 a year.

Comments 2 comments - Feb 3, 2012 - * * * * *

Animas Receives Warning Letter From the FDA

Animas Corporation, a division of Johnson & Johnson that manufactures insulin pumps, has been reprimanded by the FDA for not reporting serious problems resulting from use of its equipment. The parent company was warned that it could face fines and more for selling faulty insulin pumps and failing to disclose serious injuries to diabetic patients who used the OneTouch Ping and 2020 insulin pumps. According to reports, J&J continued to sell the pumps even after the company knew that some had failed.

Comments 1 comment - Jan 29, 2012 - * * * * *

Roche’s New Nano SmartView Meter Doesn’t Need Coding

The FDA has given Roche the go-ahead to market its Accu-Chek® Nano SmartView blood glucose monitoring system. The Nano, which uses Accu-Chek SmartView test strips, will be available to US consumers within the first half of this year. It is part of the same product line as the Accu-Chek Aviva Nano and Accu-Chek Performa Nano systems, which Roche has already launched in several overseas markets.

Comments 3 comments - Jan 22, 2012 - * * * * *

Dietary Supplements: Know Before You Swallow

A dietary supplement, also known as a food supplement or nutritional supplement, contains a "dietary ingredient" intended to supplement the diet by providing an element that might not otherwise be consumed. "Dietary ingredients" include vitamins, minerals, herbs and other botanicals, amino acids, and substances such as enzymes, organ tissues, and metabolites. Dietary supplements, which may be extracts or concentrates, come in many forms, including tablets, capsules, soft gels, gelcaps, liquids, powders, and bars.

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

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