January 25, 2008
FDA Analyzing Vytorin Study Results
Article on cnn.com -- FDA scrutinizes Vytorin. Here's an excerpt:
Government regulators said Friday they are analyzing recent study results regarding cholesterol drug Vytorin, but that it's too early to tell whether it will take any regulatory action.
The Food and Drug Administration is focusing on study results from drugmakers Merck (MRK, Fortune 500). and Schering-Plough (SGP, Fortune 500), who unveiled their study on Jan. 14. The study failed to prove that Vytorin, a combination drug containing Schering's Zetia and Merck's generic drug Zocor, is better than Zocor alone in reducing plaque in neck arteries.
But Vytorin is still seen as effective in lowering harmful types of cholesterol, which is the drug's FDA-approved purpose.
Vytorin is a $4 billion-a-year treatment, with sales split between Schering and Merck. Vytorin is a name-brand drug, and triple the cost of generic Zocor.
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