Merck: FDA won’t OK combo cholesterol drug
WHITEHOUSE STATION | Federal regulators have decided not to approve a new combination cholesterol drug made by Merck & Co., at least for now.
The drugmaker says the Food and Drug Administration informed the company it will need more data before it can approve the medicine.
The Merck experimental drug combines the company’s cholesterol drug Zetia with a generic version of rival Pfizer Inc.’s Lipitor, which had been the top-selling drug of all time.
Merck says company officials will talk with the FDA to determine the next steps for trying to win approval. Merck says some new data expected later this year may address the FDA’S concerns.