Search results for "FDA update"
Test strips recalled
Twenty lots of Abbott's FreeStyle and FreeStyle Lite blood glucose test strips were recalled.
https://diabetes.acponline.org/archives/2014/02/14/9.htm
14 Feb 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
Rosiglitazone REMS ends, new insulin approved
The FDA has determined that the Risk Evaluation and Mitigation Strategy is no longer necessary to ensure that the benefits of rosiglitazone-containing drugs outweigh their risks.
https://diabetes.acponline.org/archives/2016/01/08/6.htm
8 Jan 2016
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
Hemoglobin A1c test approved for diagnosis
The FDA recently approved the first hemoglobin A1c (HbA1c) test specifically labeled for diagnosing diabetes.
https://diabetes.acponline.org/archives/2013/08/09/8.htm
9 Aug 2013
Empagliflozin approved to treat type 2 diabetes
Empagliflozin (Jardiance), a sodium glucose co-transporter 2 inhibitor, was recently approved to treat type 2 diabetes in addition to diet and exercise, the FDA announced last week.
https://diabetes.acponline.org/archives/2014/08/08/5.htm
8 Aug 2014
Warning on DPP-4 inhibitors and insulin recall
Dipeptidyl peptidase-4 (DPP-4) inhibitors may cause joint pain that can be severe and disabling, and some insulin pods may fail, the FDA recently warned.
https://diabetes.acponline.org/archives/2015/09/11/6.htm
11 Sep 2015
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
Insulin needles failing to deploy
Several lots of the OmniPod Insulin Management System were affected by a recent field safety notification about needle mechanisms failing to deploy or demonstrating a delay in deployment.
https://diabetes.acponline.org/archives/2015/12/11/7.htm
11 Dec 2015
Combo of metformin and dapagliflozin approved
A once-daily combination pill of dapagliflozin and metformin HCl extended-release (Xigduo XR) was recently approved by the FDA.
https://diabetes.acponline.org/archives/2014/11/14/8.htm
14 Nov 2014