Search results for "FDA update"
Inhaled insulin approved
Afrezza, a rapid-acting, inhaled human insulin, was recently approved by the FDA to treat diabetes in adults.
https://diabetes.acponline.org/archives/2014/07/11/7.htm
11 Jul 2014
New GLP-1 receptor agonist approved
Albiglutide (Tanzeum), a glucagon-like peptide-1 (GLP-1) receptor agonist, was recently approved by the FDA to treat type 2 diabetes in adults, along with diet and exercise.
https://diabetes.acponline.org/archives/2014/05/09/8.htm
9 May 2014
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
Insulin pump approved for type 1 diabetes
The FDA recently approved the MiniMed 780G System for continuous delivery of basal insulin at selectable rates and the administration of insulin boluses at a selectable amount for the management of type 1 diabetes in patients ages 7 years and older requiring insulin.
https://diabetes.acponline.org/archives/2023/05/12/9.htm
12 May 2023
More metformin recalled due to nitrosamine impurity
The recall includes 33 lots of metformin hydrochloride extended-release tablets USP (750 mg) manufactured in India and distributed in the U.S.
https://diabetes.acponline.org/archives/2022/01/14/6.htm
14 Jan 2022
Insulin recalled due to potential missing label
Mylan Pharmaceuticals Inc. is recalling one batch of insulin glargine injection due to the potential for a missing label on some pens within a labeled carton.
https://diabetes.acponline.org/archives/2022/02/11/6.htm
11 Feb 2022
Drug approved to delay onset of stage 3 type 1 diabetes
The first-in-class therapy, indicated in adults and pediatric patients ages 8 years and older who currently have stage 2 type 1 diabetes, is administered by IV infusion once daily for 14 consecutive days.
https://diabetes.acponline.org/archives/2022/12/09/11.htm
9 Dec 2022
FDA issues draft guidance on blood glucose monitors
The updated recommendations apply to industry and, when finalized, will update previous guidance issued in 2016.
https://diabetes.acponline.org/archives/2018/12/14/6.htm
14 Dec 2018
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
New warnings for fluoroquinolones about risk of hypoglycemic coma
The labeling changes for fluoroquinolones will also make the mental health side effects more prominent and more consistent across the drug class.
https://diabetes.acponline.org/archives/2018/08/10/9.htm
10 Aug 2018