TCTMD

FDA Allows Claim About Oleic Acid’s Possible Heart Benefits on Labeling

The US Food and Drug Administration (FDA) will allow a new “qualified health claim” to be placed on the labels of oils with high levels of oleic acid, a monounsaturated fat, stating that consumption ...
Nasdaq

FDA Approves Labeling Update for Abbott's HeartMate 3 Heart Pump for use in Pediatric Patients

ABBOTT PARK, Ill., Dec. 17, 2020 /PRNewswire/ -- Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) has approved updated labeling for the company's HeartMate 3™ heart pump ...
FiercePharma

Delaware's Marlex Pharmaceuticals recalls 2 batches of heart failure drug after labeling mix-up

When it comes to heart failure medication, a labeling mix-up can have dire consequences. That's why Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the ...
Business Wire

U.S. FDA Grants Expanded Labeling Claim to On-X Life Technologies, Reducing Blood-Thinning Requirements for Heart Valve Patients

AUSTIN, Texas--(BUSINESS WIRE)--Thousands of Americans with On-X® Aortic Heart Valves may be able to reduce their regular blood-thinning medication regimen, thanks to an expanded labeling claim just ...