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Effient Approval History

  • FDA approved: Yes (First approved July 10th, 2009)
  • Brand name: Effient
  • Generic name: prasugrel
  • Dosage form: Tablets
  • Company: Daiichi Sankyo Company, Limited and Eli Lilly and Company
  • Treatment for: Acute Coronary Syndrome

Effient (prasugrel) is an oral antiplatelet agent for the treatment of patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention including coronary stenting.

Development History and FDA Approval Process for Effient

Jul 10, 2009Approval Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient
Jun  3, 2009Public Citizen: Antiplatelet Medication Is Unsafe, Should Not Be Approved,Says Scientist Who Helped Develop the Drug
Feb  4, 2009Prasugrel Receives Unanimous Approval Recommendation from FDA Advisory Committee
Dec 31, 2008FDA Cardio Renal Advisory Committee to Review Daiichi Sankyo, Lilly Drug Prasugrel
Oct 17, 2008Daiichi Sankyo and Lilly Respond to Speculation on Status of Prasugrel New Drug Application
Sep 29, 2008FDA Continues to Review Prasugrel New Drug Application
Jun 24, 2008FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel
Feb 22, 2008FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, Prasugrel
Jan  4, 2008Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Administration

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