FiercePharma

New FDA Approved Labeling For VYTORIN(R) (Ezetimibe/Simvastatin) Includes Results From the Study of Heart and Renal Protection

New FDA Approved Labeling For VYTORIN(R) (Ezetimibe/Simvastatin) Includes Results From the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease FDA ...
FierceBiotech

FDA narrows label for Abiomed's Impella RP heart pump after mortality rose in post-approval study

After Abiomed’s attempts to expand the user pool for its Impella RP heart pump were less than successful, the FDA has updated the wording of the device’s label to direct it toward only the patients ...
Business Wire

On-X Life Technologies Reports CE Mark Approval to Sell Its Mechanical Aortic Heart Valve with an Expanded Labeling Claim: a Reduction in the Required Use of Blood Thinners

“This approval allows European clinicians to maintain patients on a lower dose of anticoagulant, which has been shown in a multicenter clinical trial (PROACT: Prospective On-X Anticoagulation Clinical ...
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 ...
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 ...