An application for a new cholesterol pill that combines Lipitor and Zetia has been rejected by the U.S. Food and Drug Administration because it wants more information about the manufacturing and stability of the combination drug.
The unusual decision was disclosed Monday by Merck & Co., which applied to the FDA in September for approval of the two-drug pill, the Associated Press reported. Lipitor and Zetia are approved for sale in the United States.
The FDA may only have minor questions about details of test results, or agency staff may have "found something they don't like," Steve Brozak, president of WBB Securities, told the AP.
Usually, the FDA accepts applications for experimental drugs and then reviews the extensive data that accompanies the applications. Information about how often applications are rejected up front wasn't immediately available.
"We do intend to refile" with additional data, Merck spokesman Ron Rogers told the AP.