Merck Announces FDA Acceptance of New Drug Application for Vorapaxar, Investigational Anti-Thrombotic Medicine
July 24, 2013 7:00 am ET
Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the New Drug Application (NDA) for its
investigational anti-thrombotic medicine, vorapaxar, has been accepted
for standard review by the U.S. Food and Drug Administration (FDA).
Merck is seeking FDA approval of vorapaxar for the secondary prevention
of cardiovascular events in patients with a history of heart attack and
no history of stroke or transient ischemic attack (TIA).
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well. Merck is known as MSD outside the United States and Canada.
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consumer care and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
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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
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receive the necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate or
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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 patents and other protections
for innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.
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otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck’s 2012 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
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