Kos submits supplemental New Drug Application for new Niaspan CF product

By Lisa Kerner

Charlotte, N.C., July 12 - Kos Pharmaceuticals, Inc. submitted a supplemental New Drug Application to the Food and Drug Administration for a complete dosage range of Niaspan Caplet Formulation (CF) for treatment of high cholesterol.

The company said it plans to launch the product in the first quarter of 2007.

"This complete dosage range of Niaspan CF products draws upon the proven efficacy and safety of Niaspan, and could further enhance patient acceptance and compliance in addition to improving tablet aesthetics and mechanical strength," president and chief executive officer Adrian Adams said in a company news release.

The new range of Niaspan CF products includes an optimized 1,000 mg formulation of the Kos HDL-boosting therapy Niaspan (niacin once-daily, extended-release tablets).

Kos said Niaspan is the only FDA-approved once-daily prescription niacin formulation for the treatment of lipid disorders that elevates HDL, the so-called good cholesterol, by up to 26%.

Cranbury, N.J.-based Kos is a fully integrated specialty pharmaceutical company focused on the cardiovascular, metabolic and respiratory disease areas.

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