Search results for "FDA update"

Results 41 - 50 of about 57 for "FDA update".

Metformin solution recalled due to contamination

Two lots of metformin hydrochloride oral solution (Riomet), 500 mg/5 mL, were recalled due to fungal contamination, the FDA said. ... Sun Pharmaceutical Industries, Inc., has recalled two lots of metformin hydrochloride oral solution (Riomet), 500 mg/5 mL
December 2017

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. ... The FDA is requiring several postmarketing studies, including trials in
October 2014

Incretin mimetics' effects on pancreas under investigation

The FDA is investigating reports of possible increased risk of pancreatitis and precancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes. ... The FDA has asked the researchers to provide the methodology used to collect and
May 2013

New drugs approved for diabetes

The first generic version of pioglitazone hydrochloride (Actos) and a new indication for ranibizumab injection (Lucentis) were recently announced by the FDA. ... In addition, ranibizumab injection (Lucentis) received FDA approval for a new indication to
November 2012

First drug in new class approved

The FDA recently approved canaglifozin (Invokana) tablets to improve glycemic control in adults with type 2 diabetes, along with diet and exercise. ... The FDA is requiring five postmarketing studies: a cardiovascular outcomes trial; an enhanced
June 2013

Another weight loss drug approved

A combination of phentermine and topiramate extended-release (Qsymia) was recently approved by the FDA as an addition to a reduced-calorie diet and exercise for chronic weight management.
October 2012

FDA urges patients to use caution when injecting insulin with pen needles

The FDA provided recommendations to patients, caregivers, and clinicians on the proper use of both standard and safety pen needles to inject medicines in a Sept.
October 2018

New warnings for fluoroquinolones about risk of hypoglycemic coma

The FDA is requiring safety labeling changes for fluoroquinolones to strengthen warnings that the antibiotics may cause significant decreases in blood glucose levels, as well as certain mental health side effects, ... The new label changes will add an
August 2018

New GLP-1 receptor agonist approved

The FDA is requiring postmarketing studies related to pediatric use, risks of MTC, and cardiovascular outcomes. ... The most common side effects are diarrhea, nausea, and injection site reactions, according to an FDA press release.
May 2014

Single and combo diabetes drugs approved

Alogliptin (Nesina) and two new combination drugs (alogliptin and metformin hydrochloride [Kazano] and alogliptin and pioglitazone [Oseni]) were approved by the FDA to improve blood glucose control in adults with type ... The FDA is requiring five
May 2013

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