Responding to "recent media speculation regarding the status of the prasugrel new drug application," Eli Lilly and Daiichi Sankyo said they still have received no word about the fate of prasugrel, a potential blockbuster anti-clotting drug that would compete with Plavix if approved. "If approved" being the key words there. The companies have been waiting for some time for an answer. In September, the FDA once again delayed a decision after initially postponing it in June. Clinical data on prasugrel showed the drug outperformed Plavix but also increased the the risk of bleeding.
"Daiichi Sankyo and Eli Lilly reiterated today that they continue to have discussions with the FDA regarding the review of this application. The companies have not been notified of any regulatory action for the new drug application or of any decision to have an advisory committee to review prasugrel," the companies said in a joint statement.
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