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FDA update

2 FDA news release. The company also recalled two lots of metformin hydrochloride extended-release tablets USP (500 mg) due to NDMA contamination, the FDA announced on Nov.
November 2020

FDA update

The FDA has requested clinical trial data on saxagliptin (Onglyza and Kombiglyze XR) to investigate a possible increase in heart failure in patients taking the drug. ... The manufacturer is expected to submit the data to the FDA by early March 2014,
February 2014

FDA update

First, Sun Pharmaceutical Industries Inc. recalled one lot of metformin hydrochloride for extended-release oral suspension (Riomet ER; 500 mg per 5 mL) due to excess amounts of NDMA, the FDA ... In the second recall, announced by the FDA on Oct. 5,
October 2020

FDA update

https://diabetes.acponline.org/archives/2012/09/14/10.htm. Lorcaserin hydrochloride (Belviq) was recently approved by the FDA for chronic weight management in adults. ... Lorcaserin hydrochloride (Belviq) was recently approved by the FDA for chronic
September 2012

FDA update

Afrezza, a rapid-acting, inhaled human insulin, was recently approved by the FDA to treat diabetes in adults. ... The most common adverse reactions in trials were hypoglycemia, cough, and throat pain or irritation, according to an FDA.
July 2014

FDA update

Insulin and certain other biologic drugs have a new pathway for biosimilar or interchangeable products, the FDA announced on March 23. ... said. Historically, it was more difficult to develop generic versions of these biologic drugs under the Federal Food
April 2020

FDA update

A new balloon device (the ReShape Dual Balloon) was recently approved by the FDA to treat obesity without invasive surgery. ... Six months after removal, treated patients had kept off an average of 9.9 pounds, according to an FDA press release.
August 2015

FDA update

https://diabetes.acponline.org/archives/2015/03/13/9.htm. In an effort to reduce the risk of infection spread, the FDA recently required additional label warnings about sharing of ... Insulin pens and pens for other injectable diabetes medicines should
March 2015

FDA update

https://diabetes.acponline.org/archives/2016/08/12/8.htm. Lixisenatide (Adlyxin), a once-daily injection, was approved by the FDA on July 28 to improve glycemic control in adults with ... Lixisenatide (Adlyxin), a once-daily injection, was approved by
August 2016

FDA update

MiniMed 600 Series Insulin Pumps, which deliver insulin to patients with type 1 diabetes, were recently recalled by Medtronic due to incorrect insulin dosing, the FDA announced on Feb.
March 2020

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