Resources for Food and Drug Administration (FDA)

CV Therapeutics: FDA to Review Ranexa

www.chron.com

Biopharmaceutical company CV Therapeutics Inc. said Monday federal regulators will review its chest pain drug Ranexa as an initial treatment for angina.

CV wants to expand the uses for Ranexa, which is already approved as a treatment for chronic angina, or chest pain, in patients who have not responded to other anti-anginal drugs.

Now the U.S. Food and Drug Administration will review its supplemental new drug application for Ranexa (ranolazine extended-release tablets) as an initial treatment of angina. CV Therapeutics also wants the label to reflect a reduction in cautionary language.

Separately, the FDA will review a new drug application for Ranexa as well: CV Therapeutics is seeking a label change for the drug that says it also reduces the levels of hemoglobin HbA1c in coronary artery disease patients with diabetes. Hemoglobin HbA1c reflects the level of glucose in the blood.

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