Search results for "FDA update"
Metformin testing finds negligible levels of nitrosamine impurity
Levels of N-nitrosodimethylamine found in metformin products ranged from not detectable to low, and there are no U.S. recalls at this time.
https://diabetes.acponline.org/archives/2020/02/14/8.htm
14 Feb 2020
Insulin pumps recalled due to incorrect dosing
The manufacturer of the pumps, which deliver insulin to patients with type 1 diabetes, has received a total of 26,421 complaints and is aware of 2,175 injuries and one death.
https://diabetes.acponline.org/archives/2020/03/13/8.htm
13 Mar 2020
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
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
Extended-release metformin recalled due to impurity
After recommending that several manufacturers recall the diabetes drug due to excess levels of N-nitrosodimethylamine, the FDA is assessing whether the recalls will result in shortages.
https://diabetes.acponline.org/archives/2020/06/12/9.htm
12 Jun 2020
Boxed warning on amputation risk removed from canagliflozin label
Recent studies have found a lower risk of leg and foot amputation than previous studies, which in 2017 had prompted the FDA to add the warning to the sodium-glucose cotransporter-2 inhibitor.
https://diabetes.acponline.org/archives/2020/09/11/9.htm
11 Sep 2020
Extended-release metformin recalled due to impurity
Companies recently recalled metformin hydrochloride for extended-release oral suspension and metformin hydrochloride extended-release tablets USP due to excess amounts of N-nitrosodimethylamine.
https://diabetes.acponline.org/archives/2020/10/09/10.htm
9 Oct 2020
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
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
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