FDA declines to approve Merck cholesterol drug
WHITEHOUSE STATION, N.J. — The Food and Drug Administration is asking for additional data before it approves a new cholesterol drug made by Merck, the drug maker said.
Merck said the agency issued a complete response letter for its regulatory approval application for a drug that would combine the cholesterol drug Zetia (ezetimibe) with atorvastatin, the active ingredient in Pfizer's Lipitor. A complete response letter means that the FDA cannot approve a drug application in its current form.
The proposed drug is similar to the drug Vytorin, which combines ezetimibe with simvastatin. Lipitor lost patent protection at the end of November, and Ranbaxy Labs markets a generic version.