Prasugrel unanimously recommended for approval

On February 3, the FDA Cardiovascular and Renal Drugs Advisory Committee unanimously recommended that prasugrel (Daiichi Sankyo/Lilly) should be approved for the treatment of patients with acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI).

On February 3, the FDA Cardiovascular and Renal Drugs Advisory Committee unanimously recommended that prasugrel (Daiichi Sankyo/Lilly) should be approved for the treatment of patients with acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI).

FDA was originally expected to make a decision regarding prasugrel in June 2008, but the agency pushed the action date back to September 26, 2008. On that date, however, FDA announced that the agency had not completed its review. A new action date has not yet been announced.

For further information on this agent, see Formulary’s “Focus on prasugrel."