Question-and-Answer Session
Operator
Thank you. (Operator Instructions) Your first question comes from Chris Schott - J.P. Morgan.
Chris Schott - J.P. Morgan
Just two quick questions. First, on GARDASIL, can you just talk a little bit more about the geographic mix of your consolidated sales? Given the flat year-over-year guidance and some of the comments you made about the U.S. business, should we be thinking about a U.S. business that's down year-over-year for GARDASIL in 2009?
And then secondly, can you just elaborate a little bit, also, on your comments on the volatile economic environment that you referenced in the press release and some of the comments? Just to be clear, is this something you're currently already seeing in your business starting to play out or is this in anticipation of kind of a deteriorating economic environment impacting the pharmaceutical industry?
Peter N. Kellogg
On GARDASIL, you asked first how much of the business is in the U.S., and about threequarters of the business for GARDASIL is in the U.S. at this point. So you'd have to play that into kind of the U.S. versus international growth, but basically our mix is about three-quarters U.S., one-quarter ex U.S.
And regarding the volatility of the economic conditions in the markets, I'd say that we are already seeing some of the impact ex U.S. particularly of that, but also in the U.S. I think that pertains primarily to just scrip numbers and industry numbers as well. I don't know that it's disproportionately hitting our product as much as we're just seeing industry unit volume slow as we've come through the second half of this year.
Operator
Your next question comes from Tim Anderson - Sanford Bernstein.
Tim Anderson - Sanford Bernstein
On VYTORIN and ZETIA formulary position relative to late October when you and Schering held your earnings calls, have you lost any additional ground that you didn't anticipate at that time?
On GARDASIL, in your guidance how much of that is due to Glaxo's product capturing share? They claim they've won more than half of the tenders in ex U.S. markets.
And on SINGULAIR, can you update us what you expect on the pending FDA safety update and safety review?
Peter N. Kellogg
So let me take the GARDASIL one first. I think our guidance primarily is based on the penetration of cohorts and approval of new cohorts and the evolution of that growth. We obviously have factored in some thinking relative to having competition, but we actually think we're fairly well positioned competitively.
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