Search results for "FDA Update"
FDA approves new heart failure indication for SGLT-2 inhibitor
Originally approved in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes, the sodium-glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin (Jardiance) is now approved to reduce the risk of cardiovascular death and hospitalization for heart failure in adults.
https://diabetes.acponline.org/archives/2022/03/11/10.htm
11 Mar 2022
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
FDA clears marketing of mobile app for automated insulin dosing in type 1 diabetes
The prescription-only mobile application is intended for use with compatible devices for automated insulin dosing to help manage type 1 diabetes in persons ages 6 years and older.
https://diabetes.acponline.org/archives/2023/02/10/6.htm
10 Feb 2023
Insulin recalled due to potential missing label
Mylan Pharmaceuticals Inc. is recalling one batch of insulin glargine injection due to the potential for a missing label on some pens within a labeled carton.
https://diabetes.acponline.org/archives/2022/02/11/6.htm
11 Feb 2022
New warnings for fluoroquinolones about risk of hypoglycemic coma
The labeling changes for fluoroquinolones will also make the mental health side effects more prominent and more consistent across the drug class.
https://diabetes.acponline.org/archives/2018/08/10/9.htm
10 Aug 2018
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
First noninjection treatment for severe hypoglycemia approved
The nasal powder is indicated for the emergency treatment of severe hypoglycemia in patients with diabetes ages 4 years and older.
https://diabetes.acponline.org/archives/2019/08/09/8.htm
9 Aug 2019
Glucagon recalled due to detaching needles
Six batches of GlucaGen HypoKit (glucagon [rDNA origin] for injection) were recalled due to the possibility of needle detachment, the FDA recently announced.
https://diabetes.acponline.org/archives/2016/09/16/8.htm
16 Sep 2016
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
SGLT2 inhibitors associated with ketoacidosis
Sodium-glucose cotransporter-2 (SGLT2) inhibitors, including canagliflozin, dapagliflozin, and empagliflozin, may cause ketoacidosis, the FDA recently warned.
https://diabetes.acponline.org/archives/2015/06/12/8.htm
12 Jun 2015