FDA Rejects Merck's Combo Cholesterol Drug For Now

Law360, New York (March 5, 2012, 4:17 PM EST) -- Merck & Co. Inc. said Monday that federal regulators have rejected its new cholesterol drug combining the drug giant's own Zetia product with generic Lipitor, telling Merck that they need additional data about the drug before approving it.

Merck said it is planning to submit additional information about the tablets containing both Zetia, known chemically as ezetimibe, and atorvastatin, or generic Lipitor, to the U.S. Food and Drug Administration. The company hasn’t set a timeline for those actions but said that new data on the drug...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.