The FDA granted approval to Abbott's NDA for Simcor, a fixed-dose combination of Niaspan (extended-release niacin) and simvastatin, the generic version of Merck's Zocor.
The drug is indicated to raise “good” cholesterol and lower “bad” cholesterol and triglycerides in patients.
The approval for Simcor is the first for a cholesterol drug since questions cropped up last month about the effectiveness of Merck and Schering-Plough's Vytorin, which also is based on niacin.
“Simcor is really the first product that allows physicians to treat all three of the lipids at the same time,” said Jim Stolzenbach, head of clinical development for dyslipidemia at Abbott in a published report. Abbott anticipates annual sales of Simcor to hit $500 million.
As with Vytorin, it remains to be seen whether Simcor will be any better at preventing heart attacks or death than the components of the medication alone.
Abbott said it is conducting a study investigating whether Simcor is better than simvastatin or Niaspan alone. The results of that study will be available in 2011.