WHITEHOUSE STATION, New JerseyMerck & Co., Inc. announced that it has received an approvable letter from the US 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.
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 other additional data. Merck said it 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 6 months from submission of the response, per current FDA policy.
In a press release, Merck emphasized that the application for Emend for Injection and receipt of the approvable letter do 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 to prevent chemotherapy-induced nausea and vomiting.