Merck Receives Approvable Letter from FDA for Emend (fosaprepitant dimeglumine) 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.
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. For more information, visit www.merck.com.
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.
Merck & Co., Inc.
Ron Rogers, 908-423-6449
Pam Eisele, 267-305-7896
Graeme Bell, 908-423-5185
Posted: May 2007