FDA Advisory Panel Recommends Against Approval Of Merck's NDA For Non Prescription MEVACOR® (lovastatin) 20 Mg

Main Category: Cholesterol
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 17 Dec 2007 - 0:00 PDT

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Merck & Co., Inc. announced that the U.S. Food and Drug Administration's (FDA) joint panel of the Nonprescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted against recommending approval at this time of the over-the-counter (OTC) use of MEVACOR® (lovastatin) 20 mg to help lower LDL cholesterol which may prevent a first heart attack.

"We are disappointed in today's outcome. We felt we presented a compelling case to the committee that non-prescription MEVACOR 20 mg 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," said Edwin L. Hemwall, PhD, vice president, Global OTC Regulatory and Scientific Affairs.

The FDA is not bound by the committee's recommendation, but takes its advice into consideration. The anticipated action date by the FDA is Jan. 26, 2008.

About Prescription MEVACOR

MEVACOR is a prescription medicine that is approved in the U.S. for the treatment of elevated cholesterol levels that lifestyle changes alone cannot control and to reduce the risk of a first heart attack, unstable angina and coronary revascularization procedures in healthy men and women with average or moderately elevated cholesterol levels.

Important Safety Information

According to the prescribing information, MEVACOR should not be used by anyone allergic to any of its components, people with liver disease, or by women who are pregnant, breast-feeding, or likely to become pregnant. It is recommended that liver function tests be performed in all patients prior to daily use of MEVACOR 40 mg or more.

Muscle pain or weakness in patients taking prescription MEVACOR should be reported to a doctor because these could be signs of a serious side effect. Patients should tell their doctors about other medications they are taking in order to avoid possible drug interactions.

The most common adverse events reported with MEVACOR 20 mg taken once daily were diarrhea, flatulence, headache and myalgia.

Further information about MEVACOR is available on http://www.merck.com.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.

Merck forward-looking statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

MEVACOR® (lovastatin) is a registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA

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