FDA Won't Accept Merck's Application For New Drug

LINDA A. JOHNSON

TRENTON, N.J. (AP) — U.S. regulators have refused to accept drugmaker Merck & Co.'s application for a new, combination cholesterol pill that includes rival Pfizer's Lipitor, the world's top-selling drug.

Merck disclosed the rare move by the Food and Drug Administration in a regulatory filing Monday.

The company 2 1/2 years ago said it planned to make a dual cholesterol pill that at the time looked sure to be a blockbuster: a combination of Pfizer Inc.'s Lipitor — which generates nearly $13 billion in annual sales — and Zetia, a cholesterol pill Merck sells with Schering-Plough Corp. The two drugmakers have been partners on cholesterol medicines since 2000 and are about to merge.

Merck, of Whitehouse Station, N.J., applied to the FDA in September for approval of the combo pill. But Merck said the FDA refused to file the application and instead is requiring more data on the manufacturing and stability of the drug.

"For a company this size, this is not the norm," said analyst Steve Brozak, president of WBB Securities.