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
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
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
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
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
Single and combo diabetes drugs approved
Alogliptin (Nesina) and two new combination drugs (alogliptin and metformin hydrochloride [Kazano] and alogliptin and pioglitazone [Oseni]) were approved by the FDA to improve blood glucose control in adults with type 2 diabetes, along with diet and exercise.
https://diabetes.acponline.org/archives/2013/05/10/12.htm
10 May 2013
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
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