FDA Advisory Panel Recommends Against Approval of Merck's NDA for Non-prescription MEVACORÂ® (lovastatin) 20 mg
WHITEHOUSE STATION, N.J., Dec. 13, 2007 - Merck & Co., Inc. announced today 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 MEVACORÂ® (lovastatin) 20 mg to help lower LDL cholesterol which may prevent a first heart attack.
"We are disappointed in today's outcome.Â 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.Â 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.Â 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.Â 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 www.merck.com.
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first.Â Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs.Â 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.Â Merck also publishes unbiased health information as a not-for-profit service.Â For more information, visit http://www.merck.com.
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