Merck Announces FDA Acknowledgement of Resubmission of New Drug Application for Ezetimibe/Atorvastatin Tablets
January 2, 2013 4:45 pm ET
Merck (NYSE: MRK), known as MSD outside the United States and Canada,
announced today that the U.S. Food and Drug Administration (FDA) has
acknowledged the resubmission of a New Drug Application (NDA) for
ezetimibe and atorvastatin tablets, an investigational combination
medicine. The updated NDA was deemed complete for review after Merck
submitted additional data in response to the FDA’s Complete Response
Letter issued last year. Merck expects the FDA’s review to be completed
in the first half of 2013.
Merck is continuing to move forward with planned filings for the
ezetimibe and atorvastatin combination tablet in additional countries
around the world.
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This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. These statements are based
upon the current beliefs and expectations of Merck’s management and are
subject to significant risks and uncertainties. There can be no
guarantees with respect to pipeline candidates that the candidates will
receive the necessary regulatory approvals or that they will be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; Merck’s ability to accurately
predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk;
dependence on the effectiveness of Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck’s 2011 Annual Report on Form 10-K and the company’s other
filings with the Securities and Exchange Commission (SEC) available at
the SEC’s Internet site (www.sec.gov).
Pamela Eisele, 908-423-5042
Skip Irvine, 267-305-5397
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088