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Home Industry News MSD confirms FDA negative recommendation

MSD confirms FDA negative recommendation

14th December 2007

Merck, Sharp and Dohme (MSD) has confirmed that the US Food and Drug Administration’s (FDA) advisory panel has decided against approving the company’s New Drug Application for non-prescription Mevacor (lovastatin) 20mg.

The FDA joint panel of the of the Non-prescription Drugs Advisory Committee and the Endocrinologists and Metabolic Drugs Advisory Committee voted against recommending approval of the over-the-counter use of Mevacor 20mg to help lower LDL cholesterol which may prevent a first heart attack.

Edwin L Hemwall, vice-president of regulatory and scientific affairs at MSD, expressed the company’s disappointment at the decision.

“We felt we presented a compelling case to the committee that non-prescription Mevacor 20mg would be a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors and are already talking with their healthcare provider,” he said.

The joint panel’s recommendation does not bind the FDA but the regulatory body takes the advice closely into consideration.

MSD has stated that the FDA will provide their decision on the approval of Mevacor on January 26th 2008.

Also this week, MSD hosted its Annual Business Briefing where the company reviewed its progress under a new strategic plan designed to change the way the company develops and distributes its products worldwide.

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