FDA won't accept Merck's application for new drug
WHITEHOUSE STATION, N.J. (AP) — U.S. regulators won't accept drugmaker Merck's application for a new combination cholesterol pill that includes rival Pfizer's Lipitor, the world's top-selling drug.
Merck & Co. disclosed the rare move by the Food and Drug Administration in a regulatory filing on Monday.
The company had said about 2 1/2 years ago that it planned to make and market a cholesterol pill combining Pfizer Inc.'s Lipitor with Zetia, a cholesterol pill Merck jointly sells with partner Schering-Plough Corp.
In September, Merck applied to the FDA for approval of its combo pill.
But Merck says the FDA refused to file the application and instead is requiring more data on the manufacturing and stability of the drug.
The FDA hasn't responded to requests for comment.