PALO ALTO, Calif. The Food and Drug Administration will review CV Therapeutics chest pain drug Ranexa as an initial treatment for angina, according to the Associated Press.
The drug was originally approved as a treatment for chronic angina in patients who had not responded to other anti-anginal drugs. The biopharmaceutical company is also looking for label changes to reflect a reduction in cautionary language.
Separately, the FDA will review a new drug application for Ranexa; 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.
The company said the FDA has agreed to make a decision on both applications on July 27, 2008.