Search results for "FDA update"
Extended-release metformin recalled due to nitrosamine impurities
A company recently expanded a recall of metformin hydrochloride extended-release tablets USP due to excess amounts of N-nitrosodimethylamine.
https://diabetes.acponline.org/archives/2021/01/08/7.htm
8 Jan 2021
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
Glucose meter recalled due to incorrect unit of measure
The TRUE METRIX AIR Blood Glucose Meter displayed glucose results in mmol/L rather than mg/dL.
https://diabetes.acponline.org/archives/2020/05/08/7.htm
8 May 2020
FDA urges patients to use caution when injecting insulin with pen needles
The agency offered new recommendations after receiving reports of patients using standard pen needles to inject insulin without removing the inner needle cover.
https://diabetes.acponline.org/archives/2018/10/12/7.htm
12 Oct 2018
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
Metformin solution recalled due to contamination
Two lots of metformin hydrochloride oral solution (Riomet), 500 mg/5 mL, were recalled due to fungal contamination, the FDA said.
https://diabetes.acponline.org/archives/2017/12/08/7.htm
8 Dec 2017
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
Test strips recalled
The SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip may report falsely low blood glucose levels.
https://diabetes.acponline.org/archives/2016/03/11/8.htm
11 Mar 2016
Liraglutide gets new cardiovascular indication
The FDA approved a new indication for liraglutide to reduce the risk of myocardial infarction, stroke, and cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.
https://diabetes.acponline.org/archives/2017/09/08/8.htm
8 Sep 2017
First continuous glucose monitoring system with fully implantable glucose sensor approved
The sensor is coated with a fluorescent chemical that produces a small amount of light when exposed to blood glucose. Every five minutes, it sends glucose measurements to a compatible device that is running a device-specific mobile app.
https://diabetes.acponline.org/archives/2018/07/13/10.htm
13 Jul 2018