Merck Announces FDA Acknowledgement of Resubmission of New Drug Application for Ezetimibe/Atorvastatin Tablets

  Merck Announces FDA Acknowledgement of Resubmission of New Drug Application
  for Ezetimibe/Atorvastatin Tablets

Business Wire

WHITEHOUSE STATION, N.J. -- January 2, 2013

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.

About Merck

Today's Merck is a global healthcare leader working to help the world be well.
Merck is known as MSD outside the United States and Canada. Through our
prescription medicines, vaccines, biologic therapies, and consumer care and
animal health products, we work with customers and operate in more than 140
countries to deliver innovative health solutions. We also demonstrate our
commitment to increasing access to healthcare through far-reaching policies,
programs and partnerships. For more information, visit www.merck.com and
connect with us on Twitter, Facebook and YouTube.

Forward-Looking Statement

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).

Contact:

Merck
Media:
Pamela Eisele, 908-423-5042
or
Skip Irvine, 267-305-5397
or
Investors:
Carol Ferguson, 908-423-4465
or
Justin Holko, 908-423-5088
 
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