Drug: Brilinta (ticagrelor)
Company: AstraZeneca
PDUFA date: December 16, 2010
Market potential: $2 billion-$4 billion

AstraZeneca needs this win, and the advisory panel was inclined to give it to them. To win European approval in September the pharma company mounted a head-to-head trial with Plavix (2009 sales of $9.5 billion) and won on the data. Now it's looking for an FDA approval of the blood-thinner, and it's mounting a major three-year study to see if Brilinta (ticagrelor) and aspirin can help protect patients most at risk of a heart attack--something Plavix wasn't able to accomplish in a 2006 study.

One of the biggest hang-ups about Brilinta is that in the pivotal trial, Americans didn't respond as well to the therapy as people living outside the U.S., a fact that AstraZeneca attributed to higher overall use of aspirin on this side of the pond. But most of the FDA staffers who poured over the data liked what they saw--and that impressed analysts as AstraZeneca headed into the final stretch.