Merck Receives Approvable Letter from FDA for Emend (fosaprepitantdimeglumine) For Injection
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--May 11, 2007 - Merck & Co., Inc. today confirmed that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for the Company's New Drug Application (NDA) for Emend (fosaprepitant dimeglumine) For Injection, also known as MK-0517, an investigational intravenous therapy for chemotherapy-induced nausea and vomiting (CINV).
The FDA has informed Merck in the letter that before approval of the NDA can be issued, additional manufacturing validation and stability data are required as well as certain additional data. Merck is working to provide the information requested and plans to submit the data within the next few months. Once a response to the approvable letter has been submitted, FDA review of the application is targeted to be approximately six months from submission of the response, per current FDA policy.
The application for Emend For Injection and receipt of the approvable letter does not relate in any way to the manufacturing and availability of the oral formulation of Emend, which utilizes a completely different manufacturing process and remains available for patient use.
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.
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.
Emend For Injection is a registered trademark of Merck & Co., Inc.
Posted: May 2007
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