Search results for "FDA update"
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 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
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
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
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
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
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
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
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
Metformin may contain nitrosamine impurity
The FDA is investigating whether metformin in the U.S. market contains N-nitrosodimethylamine. Low levels of the impurity have been found in the drug in other countries; however, there are no U.S. recalls at this time.
https://diabetes.acponline.org/archives/2019/12/13/9.htm
13 Dec 2019