Search results for "FDA update"


 
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FDA clears marketing of first interoperable insulin pump

The pump can be used with various components of diabetes therapy systems, including automated insulin dosing systems, continuous glucose monitors, and blood glucose meters.
https://diabetes.acponline.org/archives/2019/03/08/7.htm
8 Mar 2019

First continuous glucose monitoring system approved to be used with other devices

The system is the first approved to be used with other diabetes devices, such as automated insulin-dosing systems, insulin pumps, or blood glucose meters, according to the FDA.
https://diabetes.acponline.org/archives/2018/04/13/6.htm
13 Apr 2018

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

Device approved to treat diabetic foot ulcers

The shock-wave system is intended to be used with standard diabetic ulcer care in patients ages 22 years and older with ulcers lasting more than 30 days.
https://diabetes.acponline.org/archives/2018/01/12/6.htm
12 Jan 2018

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

More metformin recalled due to nitrosamine impurities

Another company recalled four lots of metformin hydrochloride extended-release tablets USP (500 and 750 mg) this month due to the detection of excess levels of N-nitrosodimethylamine, a probable carcinogen.
https://diabetes.acponline.org/archives/2020/11/13/10.htm
13 Nov 2020

New indication approved for empagliflozin

Empagliflozin (Jardiance) is approved for a new indication—to reduce the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease.
https://diabetes.acponline.org/archives/2016/12/09/6.htm
9 Dec 2016

Semaglutide injection approved for chronic weight management

First approved to treat type 2 diabetes in 2017, the drug has a new indication for chronic weight management in adults with a body mass index (BMI) of 27 kg/m2 or greater who have at least one weight-related condition, such as type 2 diabetes, and those with a BMI of 30 kg/m2 or greater.
https://diabetes.acponline.org/archives/2021/06/11/11.htm
11 Jun 2021

Cybersecurity warning issued for certain insulin pumps

The risks are related to the pumps' wireless communication with other devices, such as blood glucose meters and continuous glucose monitoring systems.
https://diabetes.acponline.org/archives/2019/07/12/6.htm
12 Jul 2019

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

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