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
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
Recall, warning, and a new generic drug
Insulin cartridge holders were recalled, patients were warned about pre-owned test strips, and a generic form of rosiglitazone maleate and metformin hydrochloride was approved.
https://diabetes.acponline.org/archives/2017/07/14/8.htm
14 Jul 2017
Canagliflozin will receive new boxed warning about amputation risks
Canagliflozin (Invokana, Invokamet) increases patients' risk of leg and foot amputations, according to new data from two clinical trials, the FDA recently announced.
https://diabetes.acponline.org/archives/2017/06/09/7.htm
9 Jun 2017
New weight loss drug approved
Lorcaserin hydrochloride (Belviq) was recently approved by the FDA for chronic weight management in adults.
https://diabetes.acponline.org/archives/2012/09/14/10.htm
14 Sep 2012
FDA approves new treatment for diabetic foot ulcers
The approval is an expanded indication for the device, which covers the ulcer and allows skin and tissue to regenerate and heal the wound.
https://diabetes.acponline.org/archives/2016/02/12/6.htm
12 Feb 2016
New GLP-1 agonist approved
A new glucagon-like peptide-1 (GLP-1) receptor agonist, dulaglutide (Trulicity), was approved to treat type 2 diabetes, along with diet and exercise, the FDA recently announced.
https://diabetes.acponline.org/archives/2014/10/10/8.htm
10 Oct 2014
New weight loss device approved
A new balloon device (the ReShape Dual Balloon) was recently approved by the FDA to treat obesity without invasive surgery.
https://diabetes.acponline.org/archives/2015/08/14/6.htm
14 Aug 2015