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Azor Approval History

  • FDA approved: Yes (First approved September 26th, 2007)
  • Brand name: Azor
  • Generic name: amlodipine and olmesartan
  • Dosage form: Tablets
  • Previous name: amlodipine and olmesartan
  • Company: Daiichi Sankyo, Inc.
  • Treatment for: High Blood Pressure

Azor is a fixed-dose combination of two antihypertensives, the calcium channel blocker amlodipine besylate and the angiotensin receptor blocker olmesartan medoxomil. Azor is indicated for the treatment of hypertension.

Development History and FDA Approval Process for Azor

May 13, 2009Approval Azor Receives FDA Approval as First-Line Treatment for High Blood Pressure
Sep 17, 2008Daiichi Sankyo, Inc. Files Supplemental New Drug Application for Azor as Initial Therapy for High Blood Pressure
Sep 27, 2007Approval Azor Receives FDA Approval for Treatment of High Blood Pressure
Aug 21, 2007Daiichi Sankyo and Forest Laboratories Sign Letter of Intent for Co-Promotion of Azor
Nov 28, 2006Daiichi Sankyo, Inc. Announces Filing of NDA for Amlodipine Besylate / Olmesartan Medoxomil Combination for the Treatment of Hypertension

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