Search results for "FDA update"
Follow-on insulin lispro approved
The injection is approved to improve glucose control in patients ages three years and older with type 1 diabetes and in adult patients with type 2 diabetes.
https://diabetes.acponline.org/archives/2018/01/12/8.htm
12 Jan 2018
Insulin pump approved for type 1 diabetes
The FDA recently approved the MiniMed 780G System for continuous delivery of basal insulin at selectable rates and the administration of insulin boluses at a selectable amount for the management of type 1 diabetes in patients ages 7 years and older requiring insulin.
https://diabetes.acponline.org/archives/2023/05/12/9.htm
12 May 2023
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
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
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
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
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