Drug makers Eli Lilly and Daiichi Sankyo are still awaiting news from the FDA relating to the approval of their new blood thinning drug called prasugrel.
Prasugrel is an experimental drug which has been shown to benefit patients diagnosed with acute heart problems such as angina or who are at risk of blood clots.
If approved, the drug would be competing against the blockbuster drug Plavix, which is manufactured by Sanofi-Aventis SA and Bristol-Myers Squibb Co.
The patent for Plavix expires in 2011, which means if approved, prasugrel would bring in big bucks for the joint drug makers.
The FDA has recently postponed their decision pertaining to the status of the drug, but both companies insist that they have not received any form of negative feedback from the governing agency and that their drug meets all the criteria for approval.
This marks the second time that the FDA has postponed their decision pertaining to the drug.
“Daiichi Sankyo and Lilly are engaged in an ongoing dialogue with the FDA,” said Jennifer Stotka, a Lilly vice president. “We remain confident in the overall benefit-risk profile of prasugrel, and we believe this drug should be approved so that we can bring this valuable treatment option to (acute coronary syndromes) patients, a population at risk for further cardiovascular events.”
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