FDA approves Ranexa for anti-anginal use

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The FDA has approved a new, first line indication for CV Therapeutics’ Ranexa (ranolazine extended-release tablets) for the treatment of chronic angina.

The new labeling also provides information showing that Ranexa reduced arrhythmias, including ventricular arrhythmias, new onset atrial fibrillation and bradycardia in patients with coronary artery disease, according the Palo Alto, Calif.-based company. Also, the new labeling states that Ranexa reduces hemoglobin A1c (HbA1c) in patients with diabetes.

According to the revised labeling, CV Therapeutics said that Ranexa is indicated for the treatment of chronic angina and may be used alone or in combination with traditional therapies for chronic angina, such as beta blockers, calcium channel blockers and nitrates, and common cardio-protective treatments for cardiovascular disease, such as anti-platelet therapy, lipid-lowering therapy, ACE inhibitors and angiotensin receptor blockers.

While Ranexa does not reduce heart rate or blood pressure, it can be prescribed for patients taking oral erectile dysfunction treatments.