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Merck & Co., Inc. received a not approvable letter from the FDA to its New Drug Application (NDA) seeking approval for over-the-counter (OTC) MEVACOR® (lovastatin) 20 mg.
WHITEHOUSE STATION, NJ, USA | January 25, 2008 | Merck & Co., Inc. received a not approvable letter from the U.S Food and Drug Administration (FDA) to its New Drug Application (NDA) seeking approval for over-the-counter (OTC) MEVACOR® (lovastatin) 20 mg. MEVACOR OTC had been under review by the FDA since 1999; Advisory Committee reviews in 2000 and 2005 resulted in not approvable actions.
The FDA indicated in its letter that it would require a revised label and additional data from Merck in order to gain marketing approval. "We're evaluating the conditions outlined in the agency's response to determine a path forward for MEVACOR OTC," said Edwin L. Hemwall, PhD, vice president, Global OTC Regulatory and Scientific Affairs.
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
SOURCE: Merck |
