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
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
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
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
Warning on risks of canagliflozin
The FDA on Sept. 10 released a strengthened warning on canagliflozin (Invokana, Invokamet) about increased risk of bone fractures and decreased bone mineral density.
https://diabetes.acponline.org/archives/2015/10/09/7.htm
9 Oct 2015
Nearly 1.5 million insulin syringes recalled
Recalled syringes may have graduated markings that are printed incorrectly on the syringe barrel.
https://diabetes.acponline.org/archives/2021/07/09/8.htm
9 Jul 2021
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FDA issues draft guidance on blood glucose monitors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
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