May 14, 2007
Merck receives approvable letter from FDA for Emend
The FDA told Merck it will need to provide additional data to the agency before it can approve Emend, an experimental injectable drug for nausea caused by chemotherapy.
Merck said in a statement that 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 six months from submission of the response, per current FDA policy, Merck said.