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Merck & Co., Inc. today received a Not Approvable action letter from the U.S. Food and Drug Administration (FDA) for the Company's New Drug Application (NDA) for MK-0524A (ER niacin/laropiprant) for the treatment of primary hypercholesterolemia or mixed dyslipidemia
WHITEHOUSE STATION, NJ, USA | April 28, 2008 | Merck & Co., Inc. today received a Not Approvable action letter from the U.S. Food and Drug Administration (FDA) for the Company's New Drug Application (NDA) for MK-0524A (ER niacin/laropiprant) for the treatment of primary hypercholesterolemia or mixed dyslipidemia.
"We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A," said Peter S. Kim, Ph. D. executive vice president and president, Merck Research Laboratories.
"We firmly believe that MK-0524A provides physicians with an important option to manage their patients' cholesterol. We are encouraged that on April 24, the Committee for Medicinal Products for Human Use (CHMP) recommended marketing approval for MK-0524A in Europe, and we will continue to pursue approval within individual markets in the EU and around the world," added Dr. Kim.
Merck today also reaffirmed the Company's 2008 financial guidance as issued last week (www.merck.com/newsroom/press_releases/financial/2008_0421.html) and reiterated Merck's confidence in meeting its goal of double-digit annual EPS growth through 2010 excluding certain items.
"Merck's broad portfolio of medicines and vaccines, including eight products in launch phase, enables us to weather challenges that come our way," said Richard T. Clark, chairman, president and chief executive officer, Merck. "The Company remains confident that we will grow our business this year and achieve the goals outlined in our plan to win."
In the FDA's letter, the agency rejected the proposed trade name CORDAPTIVE for MK-0524A. The Company said at the appropriate time it expects to pursue the alternative trade name TREDAPTIVE for use in the United States.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck 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 www.merck.com.
SOURCE: Merck & Co., Inc. |
