Search results for "FDA update"
Glucose monitoring app, weight-loss device, medications approved
The FDA approved an app for continuous glucose monitoring, a weight-loss device, a combination diabetes pill, and a new indication for an eye medication in the past month.
https://diabetes.acponline.org/archives/2015/02/13/7.htm
13 Feb 2015
Nearly 1.5 million insulin syringes recalled
Recalled syringes may have graduated markings that are printed incorrectly on the syringe barrel.
https://diabetes.acponline.org/archives/2021/07/09/8.htm
9 Jul 2021
Safety alert and advice on CT scanning in patients with insulin pumps
The presence of an insulin pump should not preclude an appropriate and medically indicated CT scan, the FDA said.
https://diabetes.acponline.org/archives/2016/04/08/6.htm
8 Apr 2016
New long-acting insulin drugs approved
Insulin degludec injection (Tresiba) and insulin degludec/insulin aspart injection (Ryzodeg 70/30) were approved by the FDA on Sept. 25.
https://diabetes.acponline.org/archives/2015/10/09/8.htm
9 Oct 2015
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
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
Warning about serious genital infections in patients taking SGLT2 inhibitors
The FDA has identified 12 cases of necrotizing fasciitis of the perineum or Fournier's gangrene. All 12 patients were hospitalized and required surgery, and one died.
https://diabetes.acponline.org/archives/2018/09/14/8.htm
14 Sep 2018
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
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
Metformin recalled due to nitrosamine impurity
The recall includes two lots of metformin hydrochloride extended-release tablets USP (750 mg) manufactured in India and distributed in the U.S.
https://diabetes.acponline.org/archives/2021/07/09/9.htm
9 Jul 2021