The FDA has accepted GlaxoSmithKline's new drug application (NDA) for the beta-blocker Coreg CR.
The agency will review the controlled-release formulation of Coreg (carvedilol), which is designed to control dissolution and absorption of Coreg in the body, allowing for a once-daily dosing. The current version of Coreg must be taken twice a day.
Coreg is the only beta-blocking agent indicated to improve survival in patients who have experienced mild-to-severe heart failure, and is the only beta-blocker approved for those who have suffered a heart attack that reduces their heart's ability to pump
A recent study shows that Coreg CR is superior to a placebo in reducing blood pressure over a full 24-hour dosing period, the company added. The multicenter study compared three doses of Coreg CR to a placebo in patients with hypertension who may have been taking other blood pressure-lowering medications.