FDA Gives Merck That Queasy Feeling
Make a commentBy Ed Silverman // May 11th, 2007 // 5:22 pm

Merck’s hot streak may be cooling. The drugmaker was basking in the approvals granted by the FDA over the past year, but isn’t faring as well recently. First, Arcoxia was dismissed by an advisory panel last month, which wasn’t surprising, and now, the FDA wants more data on an experimental injectable form of Emend, which would be used for nausea caused by chemo.
In a bad news press release issued at 4:45 pm EST, which is after the markets closed and about the time most people are thinking about the weekend, the drugmaker says the FDA sent an approvable letter asking for more manufacturing and stability data.
Once a response is provided, Merck expects a review to take six months. The drugmaker adds that the doesn’t affect the manufacturing and availability of an oral form of Emend, which the agency approved last year for post-operative nausea.
Merck press release[tags]Emend, Merck[/tags]