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FDA rejects Merck drug application

November 3, 2009

The agency reportedly has refused to accept an application from the pharmaceutical company for a new drug.


New Jersey (WiredPRNews.com) – The Food and Drug Administration (FDA), reportedly refused an application by drugmaker Merck and Company for a new cholesterol pill. As reported by the Associated Press (AP), Merck revealed the information about the rejected application Monday in a filing.


As noted by the AP, Merck made plans to make a cholesterol pill that combined the top selling drug Lipitor produced by Pfizer Inc. and Zetia, sold by Merck and Schering-Plough Corp., prior to their merger. The FDA reportedly required additional information about the medication in rejecting the application.


Steve Brozak, president of WBB Securities, is quoted in the report as stating of the refusal of the application, “For a company this size, this is not the norm.”


Merck spokesman Ron Rogers is further quoted by the AP as stating, “We do intend to refile.”


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