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