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US regulators have told Merck & Co that it will need to providemore data before approval is granted for Emend® (fosaprepitantdimeglumine), an experimental injectable drug for chemotherapy-inducednausea and vomiting (CINV).
Merck & Co has received anapprovable letter from the Food and Drug Administration for thecompany’s New Drug Application for Emend for injection, also known asMK-0517, an investigational intravenous therapy for CINV.
Inthe letter, the FDA says additional manufacturing validation andstability data are required, as well as certain unspecified additionaldata. Merck said it is working to provide the information requested andplans to submit it within the next few months.
Merck addedthat the approvable letter “does not relate in any way to themanufacturing and availability” of the oral formulation of Emend, whichuses a completely different production process. The pill form wasapproved by the FDA in 2003.
PharmaTimes 14/5/07
