Regulators reject Merck's proposed combo cholesterol drug
By The Associated Press
November 02, 2009, 1:18PM
The Associated PressThe drug maker Merck had hoped to combine Lipitor with its own cholesterol-fighter Zetia.
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 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, which is based in Whitehouse Station, says the FDA refused to file the application and instead is requiring more data on the manufacturing and stability of the drug.
The FDA did not respond to requests for comment.
Shares of Merck were unchanged in early afternoon trading.
Monday, November 02, 2009
Regulators reject Merck's proposed combo cholesterol drug | New Jersey Business - - NJ.com
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