Search results for "FDA update"
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
FDA authorizes marketing of first interoperable, automated insulin dosing controller
The device automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump and integrated continuous glucose monitor.
https://diabetes.acponline.org/archives/2020/01/10/6.htm
10 Jan 2020
Glucose monitoring system approved specifically for critical care units
The FDA recently approved a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized.
https://diabetes.acponline.org/archives/2014/11/14/7.htm
14 Nov 2014
Abbot FreeStyle Insulinx meters recalled
The Abbott FreeStyle Insulinx blood glucose meters were recently recalled because at extremely high blood glucose levels of 1,024 mg/dL and above, the meters will display and store in memory an incorrect test result that is 1,024 mg/dL below the measured result.
https://diabetes.acponline.org/archives/2013/07/12/9.htm
12 Jul 2013
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
Glucose meter recalled due to incorrect unit of measure
The TRUE METRIX AIR Blood Glucose Meter displayed glucose results in mmol/L rather than mg/dL.
https://diabetes.acponline.org/archives/2020/05/08/7.htm
8 May 2020
First drug in new class approved
The FDA recently approved canaglifozin (Invokana) tablets to improve glycemic control in adults with type 2 diabetes, along with diet and exercise.
https://diabetes.acponline.org/archives/2013/06/14/10.htm
14 Jun 2013
New GLP-1 agonist approved
A new glucagon-like peptide-1 (GLP-1) receptor agonist, dulaglutide (Trulicity), was approved to treat type 2 diabetes, along with diet and exercise, the FDA recently announced.
https://diabetes.acponline.org/archives/2014/10/10/8.htm
10 Oct 2014
Metformin testing finds negligible levels of nitrosamine impurity
Levels of N-nitrosodimethylamine found in metformin products ranged from not detectable to low, and there are no U.S. recalls at this time.
https://diabetes.acponline.org/archives/2020/02/14/8.htm
14 Feb 2020
Insulin, other biologics gain new pathway for biosimilars
The FDA expects that the regulatory transition, mandated by Congress, will support market competition and increase patient access to these drugs.
https://diabetes.acponline.org/archives/2020/04/10/9.htm
10 Apr 2020