Search results for "FDA update"

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CGM system approved for use without finger sticks

A continuous glucose monitoring (CGM) system was approved and some infusion sets were recalled, the FDA recently announced.
13 Oct 2017

Alert on canagliflozin and amputations

An ongoing clinical trial found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with canagliflozin (Invokana, Invokamet), according to an FDA safety alert.
10 Jun 2016

Metformin recalled due to nitrosamine impurity

The recall includes two lots of metformin hydrochloride extended-release tablets USP (750 mg) manufactured in India and distributed in the U.S.
9 Jul 2021

Warning about serious genital infections in patients taking SGLT2 inhibitors

The FDA has identified 12 cases of necrotizing fasciitis of the perineum or Fournier's gangrene. All 12 patients were hospitalized and required surgery, and one died.
14 Sep 2018

Liraglutide gets new cardiovascular indication

The FDA approved a new indication for liraglutide to reduce the risk of myocardial infarction, stroke, and cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.
8 Sep 2017

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.
9 Oct 2015

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.
12 Feb 2016

First continuous glucose monitoring system with fully implantable glucose sensor approved

The sensor is coated with a fluorescent chemical that produces a small amount of light when exposed to blood glucose. Every five minutes, it sends glucose measurements to a compatible device that is running a device-specific mobile app.
13 Jul 2018

New long-acting insulin drugs approved

Insulin degludec injection (Tresiba) and insulin degludec/insulin aspart injection (Ryzodeg 70/30) were approved by the FDA on Sept. 25.
9 Oct 2015

SGLT2 inhibitors associated with ketoacidosis

Sodium-glucose cotransporter-2 (SGLT2) inhibitors, including canagliflozin, dapagliflozin, and empagliflozin, may cause ketoacidosis, the FDA recently warned.
12 Jun 2015

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