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Kengreal Approval History

FDA Approved: Yes (First approved June 22, 2015)
Brand name: Kengreal
Generic name: cangrelor
Dosage form: for Injection
Company: The Medicines Company
Treatment for: Percutaneous Coronary Intervention

Kengreal (cangrelor) is an intravenous P2Y12 platelet inhibitor indicated for use in patients undergoing Percutaneous Coronary Intervention (PCI) to reduce the risk of periprocedural thrombotic events.

Development History and FDA Approval Process for Kengreal

DateArticle
Jun 22, 2015Approval FDA Approves Antiplatelet Agent Kengreal (cangrelor) as Adjunct to Percutaneous Coronary Intervention
Apr 15, 2015FDA Advisory Committee Recommends Approval of The Medicines Company's Antiplatelet Therapy Cangrelor
Apr 30, 2014The Medicines Company Receives Complete Response Letter From FDA for Antiplatelet Agent Cangrelor
Feb 12, 2014FDA Advisory Committee Recommends Against Antiplatelet Therapy Cangrelor
Sep  3, 2013Totality of Data From Three Phase III Trials of The Medicines Company's Intravenous Cangrelor Presented and Published
Jul  1, 2013FDA Accepts the Filing of The Medicines Company's New Drug Application for Intravenous Antiplatelet Agent Cangrelor

Further information

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