Abbott Announces Approval of Coated Niaspan Tablets

The FDA has approved Abbott's new coated Niaspan extended-release tablets, the company announced.

"With the FDA approval of a new Niaspan coated tablet, our next step is to expand upon two published studies to determine the effect on flushing intensity. We'll do that by initiating larger clinical studies," Eugene Sun, vice president of Global Pharmaceutical Clinical Development, said.

Niaspan (niacin) is the only FDA-approved, once-daily, extended-release prescription niacin formulation for the treatment of lipid disorders with an ability to significantly raise HDL cholesterol. Collective results from three major clinical studies show an average 22 percent increase of HDL for patients receiving 2,000 mg of Niaspan at bedtime.

Niacin is also indicated for the secondary prevention of heart attacks, and in combination with a bile acid binding resin to promote regression of coronary atherosclerosis in patients with history of coronary artery disease.

"More and more, physicians and their patients understand that good cholesterol management means trying to bring all lipid parameters to optimal levels," Richard Karas, professor at the Tufts-New England Medical Center, said. "Introducing a new coated tablet that may enhance patient convenience is an important factor in improving our ability to provide good cholesterol management for our patients," he added.