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

Wed Jan 2, 2013 4:45pm EST

* Reuters is not responsible for the content in this press release.

http://pdf.reuters.com/htmlnews/8knews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20130102:nBw026065a

WHITEHOUSE STATION, N.J.--(Business Wire)--
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).

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 

Copyright Business Wire 2013