Search results for "FDA update"
First continuous glucose monitoring system with fully implantable glucose sensor approved
The sensor is coated with a fluorescent chemical that produces a small amount of light when exposed to blood glucose. Every five minutes, it sends glucose measurements to a compatible device that is running a device-specific mobile app.
https://diabetes.acponline.org/archives/2018/07/13/10.htm
13 Jul 2018
Follow-on insulin lispro approved
The injection is approved to improve glucose control in patients ages three years and older with type 1 diabetes and in adult patients with type 2 diabetes.
https://diabetes.acponline.org/archives/2018/01/12/8.htm
12 Jan 2018
Glucagon emergency kits recalled due to loss of potency
A product complaint reported that the vial of glucagon in the kit was in liquid form instead of powder form. This could cause it to fail to treat severe hypoglycemia due to loss of potency, the FDA said.
https://diabetes.acponline.org/archives/2021/10/08/8.htm
8 Oct 2021
Saxagliptin under analysis for heart failure risk
The FDA has requested clinical trial data on saxagliptin (Onglyza and Kombiglyze XR) to investigate a possible increase in heart failure in patients taking the drug.
https://diabetes.acponline.org/archives/2014/02/14/8.htm
14 Feb 2014
New drugs approved for diabetes
The first generic version of pioglitazone hydrochloride (Actos) and a new indication for ranibizumab injection (Lucentis) were recently announced by the FDA.
https://diabetes.acponline.org/archives/2012/11/09/9.htm
9 Nov 2012
Another weight loss drug approved
A combination of phentermine and topiramate extended-release (Qsymia) was recently approved by the FDA as an addition to a reduced-calorie diet and exercise for chronic weight management.
https://diabetes.acponline.org/archives/2012/10/12/10.htm
12 Oct 2012
Boxed warning on amputation risk removed from canagliflozin label
Recent studies have found a lower risk of leg and foot amputation than previous studies, which in 2017 had prompted the FDA to add the warning to the sodium-glucose cotransporter-2 inhibitor.
https://diabetes.acponline.org/archives/2020/09/11/9.htm
11 Sep 2020
New GLP-1 receptor agonist approved
Albiglutide (Tanzeum), a glucagon-like peptide-1 (GLP-1) receptor agonist, was recently approved by the FDA to treat type 2 diabetes in adults, along with diet and exercise.
https://diabetes.acponline.org/archives/2014/05/09/8.htm
9 May 2014
Extended-release metformin recalled due to nitrosamine impurities
A company recently expanded a recall of metformin hydrochloride extended-release tablets USP due to excess amounts of N-nitrosodimethylamine.
https://diabetes.acponline.org/archives/2021/01/08/7.htm
8 Jan 2021
New labels warn against sharing multi-dose insulin pens
In an effort to reduce the risk of infection spread, the FDA recently required additional label warnings about sharing of multi-dose diabetes pen devices, which are intended for single patient use only.
https://diabetes.acponline.org/archives/2015/03/13/9.htm
13 Mar 2015